Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-02 @ 3:31 AM
Study NCT ID:
NCT05103332
Status:
COMPLETED
Last Update Posted:
2025-11-03
First Post:
2021-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007190', 'term': 'Indapamide'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'C437965', 'term': 'olmesartan'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@alnylam.com', 'phone': '866-330-0326', 'title': 'Chief Medical Officer', 'organization': 'Alnylam Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Run-in: 4 weeks; DB Period (DBP): Day1 to Month6 (168 days); Zilebesiran (zil) Treatment Period: First zil dose to 6 months after last dose [Placebo (pbo)/Zil: Months 6 to 30 (672 days); Zil/Zil: Day1 to Month30 (840 days)]; SFU: 6 months (168 days); 1 month=28 days. Run-in: Participants eligible after run-in who received at least 1 dose of study drug in DBP, grouped per their background medication. DBP: mSAS; SFU: Participants from mSAS, grouped per last treatment in DB/OLE before SFU entry.', 'description': "As pre-specified in SAP, after DBP, AEs were reported by treatment sequence (Zil/Zil or pbo/Zil) for zilebesiran treatment period using All Zilebesiran Treated Set (Arms 10-15). Zil/Zil arm received zilebesiran in both DB \\& OLE. Hence, AEs' data for DB+OLE have been reported together. This set gives AEs for all participants receiving zilebesiran, including participants on zilebesiran during DB \\& continuing it after Month 6 \\& those on placebo in DB later \\& switching to zilebesiran after Month 6.", 'eventGroups': [{'id': 'EG000', 'title': 'Run-in: Indapamide', 'description': 'Participants who cleared screening received open-label therapy with indapamide 2.5 mg orally once daily (QD) as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 0, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Run-in: Amlodipine', 'description': 'Participants who cleared screening received open-label therapy with amlodipine 5 mg orally QD as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.', 'otherNumAtRisk': 238, 'deathsNumAtRisk': 238, 'otherNumAffected': 0, 'seriousNumAtRisk': 238, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Run-in: Olmesartan', 'description': 'Participants who cleared screening received open-label therapy with olmesartan 40 mg orally QD \\[or 20 mg orally QD for participants with creatinine clearance ≤ 60 mL/min at screening enrolled at sites outside of the US\\] as their protocol-specified background antihypertensive medication during a Run-in period of at least 4 weeks.', 'otherNumAtRisk': 293, 'deathsNumAtRisk': 293, 'otherNumAffected': 0, 'seriousNumAtRisk': 293, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 11, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 14, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 21, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 26, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 29, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 41, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG009', 'title': 'DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 19, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 6, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG012', 'title': 'DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 36, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG013', 'title': 'DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 23, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG014', 'title': 'DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 51, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG015', 'title': 'DB (Placebo) to SFU [Indapamide Cohort]', 'description': 'Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.\n\nNo treatment was administered in SFU.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'DB (Zilebesiran) to SFU or OLE to SFU [Indapamide Cohort]', 'description': 'Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.\n\nNo treatment was administered in SFU.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 0, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG017', 'title': 'DB (Placebo) to SFU [Amlodipine Cohort]', 'description': 'Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.\n\nNo treatment was administered in SFU.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG018', 'title': 'DB (Zilebesiran) to SFU or OLE to SFU [Amlodipine Cohort]', 'description': 'Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.\n\nNo treatment was administered in SFU.', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 0, 'seriousNumAtRisk': 166, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG019', 'title': 'DB (Placebo) to SFU [Olmesartan Cohort]', 'description': 'Participants treated with placebo during DB period who did not enter the OLE period (prior to Amendment 3) or who discontinued treatment during the DB period entered the SFU period for safety monitoring.\n\nNo treatment was administered in SFU.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG020', 'title': 'DB (Zilebesiran) to SFU or OLE to SFU [Olmesartan Cohort]', 'description': 'Prior to Amendment 3, participants treated with zilebesiran who did not enter the OLE Period or who discontinued treatment (zilebesiran) during the DB period entered the SFU period for safety monitoring.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly. Participants who were already in OLE period (after completing treatment with zilebesiran/placebo in DB period) did not receive any additional study drug in OLE and transitioned to the SFU period for safety monitoring.\n\nNo treatment was administered in SFU.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 0, 'seriousNumAtRisk': 214, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 148, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 148, 'numAffected': 7}, {'groupId': 'EG015', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 118, 'numAffected': 9}, {'groupId': 'EG013', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG014', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG015', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG014', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG015', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG013', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG014', 'numAtRisk': 148, 'numAffected': 10}, {'groupId': 'EG015', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 148, 'numAffected': 11}, {'groupId': 'EG009', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG013', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 148, 'numAffected': 12}, {'groupId': 'EG015', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 148, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG013', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG014', 'numAtRisk': 148, 'numAffected': 7}, {'groupId': 'EG015', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 293, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 145, 'numAffected': 17}, {'groupId': 'EG008', 'numAtRisk': 148, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG013', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG014', 'numAtRisk': 148, 'numAffected': 14}, {'groupId': 'EG015', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 214, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-15.7', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '-7.6', 'pValueComment': 'MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \\& BA estimated glomerular filtration rate (eGFR). Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.24', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \\& handle primary \\& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \\< 0.05. Data for SBP, assessed using ABPM, while participants were on \\& within 2 weeks after stopping any escape medication were censored for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was the average of the hourly means. Least squares (LS) mean and standard error (SE) were calculated using a mixed model repeated measures (MMRM) approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'PRIMARY', 'title': 'Amlodipine: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.7', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '-6.6', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.61', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \\& handle primary \\& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \\< 0.05. Data for SBP, assessed using ABPM, while participants were on \\& within 2 weeks after stopping any escape medication were censored for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was the average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'PRIMARY', 'title': 'Olmesartan: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocolspecified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.0183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '-0.8', 'pValueComment': 'MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \\& BA eGFR. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.89', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \\& handle primary \\& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \\< 0.05. Data for SBP, assessed using ABPM, while subjects were on \\& within 2 weeks after stopping any escape medication were censored for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm.\n\nOverall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Change From Baseline at Month 3 in Office SBP - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '-19.3', 'spread': '1.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.5', 'ciLowerLimit': '-22.8', 'ciUpperLimit': '-14.2', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.17', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \\< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '-7.3', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.88', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the area under the curve (AUC) of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.6', 'ciLowerLimit': '-16.9', 'ciUpperLimit': '-10.3', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.66', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05. All collected data for office SBP were included in the analysis for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '64.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.39', 'ciLowerLimit': '4.61', 'ciUpperLimit': '33.29', 'pValueComment': 'Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Change From Baseline at Month 3 in 24-hour Mean Diastolic Blood Pressure (DBP), Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Change From Baseline at Month 3 in Office DBP - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': '24-hour Mean SBP', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-15.4', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': '24-hour Mean DBP', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-17.2', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': '24-hour Mean SBP', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-16.1', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': '24-hour Mean DBP', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-7.2', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '-15.5', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Change in Daytime Mean SBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-15.9', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-15.9', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.5', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-16.4', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-13.5', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '-14.2', 'spread': '2.05', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '-15.2', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, and Month 2, 3 and 6', 'description': 'ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.'}, {'type': 'SECONDARY', 'title': 'Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Add-on to Indapamide)', 'description': 'Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'Zilebesiran (Add-on to Indapamide)', 'description': 'Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Percent Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.37', 'spread': '29.27', 'groupId': 'OG000'}, {'value': '-91.99', 'spread': '17.89', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.90', 'spread': '26.11', 'groupId': 'OG000'}, {'value': '-92.48', 'spread': '28.49', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.34', 'spread': '32.24', 'groupId': 'OG000'}, {'value': '-95.50', 'spread': '15.91', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.86', 'spread': '28.19', 'groupId': 'OG000'}, {'value': '-94.80', 'spread': '17.89', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '30.86', 'groupId': 'OG000'}, {'value': '-92.28', 'spread': '21.64', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '26.19', 'groupId': 'OG000'}, {'value': '-93.08', 'spread': '17.07', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.81', 'spread': '26.12', 'groupId': 'OG000'}, {'value': '-91.92', 'spread': '16.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Pharmacodynamic (PD) Analysis Set included all participants who received at least 1 full dose of study drug. All by-treatment analyses based on the Modified PD Analysis Set were grouped according to the treatment actually received. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Change From Baseline at Month 3 in Office SBP - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.2', 'ciLowerLimit': '-13.4', 'ciUpperLimit': '-6.9', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.67', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \\< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '-5.3', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.36', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.6', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '-6.3', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.16', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05. All collected data for office SBP were included in the analysis for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '39.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.08', 'ciLowerLimit': '2.43', 'ciUpperLimit': '10.61', 'pValueComment': 'Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Change From Baseline at Month 3 in 24-hour Mean DBP, Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Change From Baseline at Month 3 in Office DBP - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': '24-hour Mean SBP', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': '24-hour Mean DBP', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-11.3', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': '24-hour Mean SBP', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': '24-hour Mean DBP', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-12.6', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Change in Daytime Mean SBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, and Month 2, 3 and 6', 'description': 'ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.'}, {'type': 'SECONDARY', 'title': 'Amlodipine: Percent Change From Baseline in Serum AGT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Add-on to Amlodipine)', 'description': 'Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Percent Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.67', 'spread': '22.81', 'groupId': 'OG000'}, {'value': '-92.80', 'spread': '15.99', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.62', 'spread': '35.83', 'groupId': 'OG000'}, {'value': '-95.35', 'spread': '21.36', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.23', 'spread': '35.17', 'groupId': 'OG000'}, {'value': '-97.45', 'spread': '8.59', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.78', 'spread': '34.90', 'groupId': 'OG000'}, {'value': '-96.37', 'spread': '11.24', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.42', 'spread': '41.83', 'groupId': 'OG000'}, {'value': '-96.52', 'spread': '8.41', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.81', 'spread': '37.94', 'groupId': 'OG000'}, {'value': '-93.87', 'spread': '19.20', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.51', 'spread': '48.05', 'groupId': 'OG000'}, {'value': '-94.52', 'spread': '9.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified PD Analysis Set included all participants who received at least 1 full dose of study drug. All by-treatment analyses based on the Modified PD Analysis Set were grouped according to the treatment actually received. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Change From Baseline at Month 3 in Office SBP - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.7', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '-3.3', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.76', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \\< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.2103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '1.0', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.42', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-10.8', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '-2.3', 'pValueComment': 'MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'estimateComment': 'LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05. All collected data for office SBP were included in the analysis for this endpoint.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.1230', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '0.87', 'ciUpperLimit': '3.23', 'pValueComment': 'Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.', 'groupDescription': 'A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \\< 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Change From Baseline at Month 3 in 24-hour Mean DBP, Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Change From Baseline at Month 3 in Office DBP - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': '24-hour Mean SBP', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': '24-hour Mean DBP', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 3.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': '24-hour Mean SBP', 'categories': [{'measurements': [{'value': '-9.2', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': '24-hour Mean DBP', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Office SBP', 'categories': [{'measurements': [{'value': '-11.9', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Office DBP', 'categories': [{'measurements': [{'value': '-7.0', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Overall number analyzed is the number of participants with data available for analysis at Month 6.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Change in Daytime Mean SBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean SBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Change in Daytime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change in Nighttime Mean DBP at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, and Month 2, 3 and 6', 'description': 'ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.'}, {'type': 'SECONDARY', 'title': 'Olmesartan: Percent Change From Baseline in Serum AGT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Add-on to Olmesartan)', 'description': 'Participants received placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'OG001', 'title': 'Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants received zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}], 'classes': [{'title': 'Percent Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.08', 'spread': '86.70', 'groupId': 'OG000'}, {'value': '-87.83', 'spread': '35.99', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.64', 'spread': '28.05', 'groupId': 'OG000'}, {'value': '-92.61', 'spread': '25.21', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.87', 'spread': '29.58', 'groupId': 'OG000'}, {'value': '-92.58', 'spread': '29.50', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.45', 'spread': '28.36', 'groupId': 'OG000'}, {'value': '-92.98', 'spread': '23.98', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.62', 'spread': '27.62', 'groupId': 'OG000'}, {'value': '-91.66', 'spread': '25.44', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.82', 'spread': '31.65', 'groupId': 'OG000'}, {'value': '-91.14', 'spread': '24.14', 'groupId': 'OG001'}]}]}, {'title': 'Percent Change from Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '26.66', 'groupId': 'OG000'}, {'value': '-88.22', 'spread': '41.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified PD Analysis Set included all participants who received at least 1 full dose of study drug. All by-treatment analyses based on the Modified PD Analysis Set were grouped according to the treatment actually received. Number analyzed are unique number of participants out of all the assessed participants who were evaluable for the specified category. Different participants may have contributed data for each category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'FG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'FG002', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'FG003', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'FG004', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'FG005', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'FG006', 'title': 'DB Period (Placebo) to OLE Period (Zilebesiran) [Indapamide Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.'}, {'id': 'FG007', 'title': 'DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Indapamide Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with indapamide was discontinued at the start of OLE period.'}, {'id': 'FG008', 'title': 'DB Period (Placebo) to OLE Period (Zilebesiran) [Amlodipine Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.'}, {'id': 'FG009', 'title': 'DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Amlodipine Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with amlodipine was discontinued at the start of OLE period.'}, {'id': 'FG010', 'title': 'DB Period (Placebo) to OLE Period (Zilebesiran) [Olmesartan Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and received treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.'}, {'id': 'FG011', 'title': 'DB Period (Zilebesiran) to OLE Period (Zilebesiran) [Olmesartan Cohort]', 'description': 'Prior to Amendment 3, participants who completed the DB period before a separate OLE study was available, entered the OLE period of this study and continued treatment with zilebesiran 600 mg SC q6M. Protocol-specified background antihypertensive treatment with olmesartan was discontinued at the start of OLE period.'}, {'id': 'FG012', 'title': 'DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Indapamide Cohort]', 'description': 'Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.'}, {'id': 'FG013', 'title': 'DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Indapamide Cohort]', 'description': 'Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.'}, {'id': 'FG014', 'title': 'DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Amlodipine Cohort]', 'description': 'Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.'}, {'id': 'FG015', 'title': 'DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Amlodipine Cohort]', 'description': 'Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.'}, {'id': 'FG016', 'title': 'DB (Placebo) to SFU or OLE (Zilebesiran) to SFU [Olmesartan Cohort]', 'description': 'Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (placebo) during DB period entered SFU period.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.'}, {'id': 'FG017', 'title': 'DB (Zilebesiran) to SFU or OLE (Zilebesiran) to SFU [Olmesartan Cohort]', 'description': 'Prior to Amendment 3, participants who did not enter OLE period or who discontinued treatment (zilebesiran) during DB period entered SFU period.\n\nUpon implementation of Amendment 3, participants who completed the DB period entered the SFU period directly, and those already in OLE period did not receive any additional study drug in OLE and transitioned to the SFU period.'}], 'periods': [{'title': 'DB Period (6 Months=168 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '120'}, {'groupId': 'FG004', 'numSubjects': '146'}, {'groupId': 'FG005', 'numSubjects': '147'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Modified Full Analysis Set (mFAS)', 'comment': 'mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '118'}, {'groupId': 'FG004', 'numSubjects': '146'}, {'groupId': 'FG005', 'numSubjects': '147'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Modified Safety Analysis Set (mSAS)', 'comment': 'mSAS included all participants who received any amount of the study drug. Participants were grouped according to the treatment actually received. 1 participant randomized to Placebo (Olmesartan) received zilebesiran, hence, was considered in the Zilebesiran (Olmesartan) arm for safety analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '118'}, {'groupId': 'FG004', 'numSubjects': '145'}, {'groupId': 'FG005', 'numSubjects': '148'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '114'}, {'groupId': 'FG003', 'numSubjects': '115'}, {'groupId': 'FG004', 'numSubjects': '143'}, {'groupId': 'FG005', 'numSubjects': '139'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Participant Stopped Participation in the Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}, {'title': 'OLE Period (24 Months=672 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Participants who completed the 6-month DB period and met the eligibility criteria as per the study plan before implementation of protocol amendment 3 entered the OLE period.', 'groupId': 'FG006', 'numSubjects': '26'}, {'comment': 'Participants who completed the 6-month DB period and met the eligibility criteria as per the study plan before implementation of protocol amendment 3 entered the OLE period.', 'groupId': 'FG007', 'numSubjects': '30'}, {'comment': 'Participants who completed the 6-month DB period and met the eligibility criteria as per the study plan before implementation of protocol amendment 3 entered the OLE period.', 'groupId': 'FG008', 'numSubjects': '48'}, {'comment': 'Participants who completed the 6-month DB period and met the eligibility criteria as per the study plan before implementation of protocol amendment 3 entered the OLE period.', 'groupId': 'FG009', 'numSubjects': '44'}, {'comment': 'Participants who completed the 6-month DB period and met the eligibility criteria as per the study plan before implementation of protocol amendment 3 entered the OLE period.', 'groupId': 'FG010', 'numSubjects': '66'}, {'comment': 'Participants who completed the 6-month DB period and met the eligibility criteria as per the study plan before implementation of protocol amendment 3 entered the OLE period.', 'groupId': 'FG011', 'numSubjects': '60'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '23'}, {'groupId': 'FG007', 'numSubjects': '29'}, {'groupId': 'FG008', 'numSubjects': '47'}, {'groupId': 'FG009', 'numSubjects': '42'}, {'groupId': 'FG010', 'numSubjects': '63'}, {'groupId': 'FG011', 'numSubjects': '56'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}]}]}, {'title': 'SFU Period (6 Months=168 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'comment': 'Upon implementation of Amendment 3, all participants who had completed the DB period entered the SFU period, and those in the OLE period did not receive any additional study drug in OLE and entered the SFU period.', 'groupId': 'FG012', 'numSubjects': '63'}, {'comment': 'Upon implementation of Amendment 3, all participants who had completed the DB period entered the SFU period, and those in the OLE period did not receive any additional study drug in OLE and entered the SFU period.', 'groupId': 'FG013', 'numSubjects': '59'}, {'comment': 'Upon implementation of Amendment 3, all participants who had completed the DB period entered the SFU period, and those in the OLE period did not receive any additional study drug in OLE and entered the SFU period.', 'groupId': 'FG014', 'numSubjects': '114'}, {'comment': 'Upon implementation of Amendment 3, all participants who had completed the DB period entered the SFU period, and those in the OLE period did not receive any additional study drug in OLE and entered the SFU period.', 'groupId': 'FG015', 'numSubjects': '115'}, {'comment': 'Upon implementation of Amendment 3, all participants who had completed the DB period entered the SFU period, and those in the OLE period did not receive any additional study drug in OLE and entered the SFU period.', 'groupId': 'FG016', 'numSubjects': '143'}, {'comment': 'Upon implementation of Amendment 3, all participants who had completed the DB period entered the SFU period, and those in the OLE period did not receive any additional study drug in OLE and entered the SFU period.', 'groupId': 'FG017', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '57'}, {'groupId': 'FG013', 'numSubjects': '55'}, {'groupId': 'FG014', 'numSubjects': '106'}, {'groupId': 'FG015', 'numSubjects': '104'}, {'groupId': 'FG016', 'numSubjects': '133'}, {'groupId': 'FG017', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '4'}, {'groupId': 'FG014', 'numSubjects': '8'}, {'groupId': 'FG015', 'numSubjects': '11'}, {'groupId': 'FG016', 'numSubjects': '10'}, {'groupId': 'FG017', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '5'}, {'groupId': 'FG015', 'numSubjects': '3'}, {'groupId': 'FG016', 'numSubjects': '4'}, {'groupId': 'FG017', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}]}, {'type': 'Participant Stopped Participation in the Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '4'}, {'groupId': 'FG013', 'numSubjects': '3'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '7'}, {'groupId': 'FG016', 'numSubjects': '6'}, {'groupId': 'FG017', 'numSubjects': '5'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '1'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 78 clinical sites in North America (66=United States \\[US\\] \\& 12=Canada) \\& 24 clinical sites in Europe (10=United Kingdom \\[UK\\]) enrolled participants in this study. 663 participants who met eligibility criteria after run-in with protocol-assigned background medication (indapamide, amlodipine, olmesartan) were randomized to zilebesiran or placebo in double-blind (DB) period, with the option to receive zilebesiran in open-label extension period (OLE). 1 month=28 days for this study.', 'preAssignmentDetails': 'Before Protocol Amendment 3 (PA3), participants completing DB period could join a separate zilebesiran OLE study. Those completing DB before OLE study availability entered OLE period in this study to receive zilebesiran until transition. Others ineligible for OLE study/discontinued drug in DB could enter safety follow-up(SFU). With PA3, OLE period was closed \\& plans for OLE study canceled. Ongoing DB participants entered SFU at completion; those in OLE stopped treatment \\& transitioned to SFU.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}, {'value': '147', 'groupId': 'BG005'}, {'value': '658', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'DB Period: Placebo (Add-on to Indapamide)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a subcutaneous (SC) injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'BG001', 'title': 'DB Period: Zilebesiran (Add-on to Indapamide)', 'description': 'Participants were randomized to receive zilebesiran, 600 milligrams (mg), as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to indapamide. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'BG002', 'title': 'DB Period: Placebo (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'BG003', 'title': 'DB Period: Zilebesiran (Add-on to Amlodipine)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to amlodipine. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'BG004', 'title': 'DB Period: Placebo (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive placebo matched to zilebesiran, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'BG005', 'title': 'DB Period: Zilebesiran (Add-on to Olmesartan)', 'description': 'Participants were randomized to receive zilebesiran, 600 mg, as a SC injection, on Day 1 of the 6-month DB treatment period as an add-on therapy to olmesartan. Starting at Month 3, additional conventional oral antihypertensives ("escape antihypertensive medications") may be added to the participant\'s protocol-specified background antihypertensive medication per Investigator judgement.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '10.2', 'groupId': 'BG003'}, {'value': '57.7', 'spread': '10.6', 'groupId': 'BG004'}, {'value': '59.3', 'spread': '10.4', 'groupId': 'BG005'}, {'value': '58.5', 'spread': '10.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '282', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}, {'value': '87', 'groupId': 'BG005'}, {'value': '376', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '225', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '88', 'groupId': 'BG005'}, {'value': '431', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '187', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '106', 'groupId': 'BG005'}, {'value': '433', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)', 'classes': [{'categories': [{'measurements': [{'value': '143.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '143.4', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '142.6', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '143.3', 'spread': '7.8', 'groupId': 'BG003'}, {'value': '144.2', 'spread': '8.3', 'groupId': 'BG004'}, {'value': '143.6', 'spread': '8.2', 'groupId': 'BG005'}, {'value': '143.4', 'spread': '8.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'SBP assessed by ABPM at baseline is reported here. 24-hour ABPM device was programmed to take readings every 20 minutes during day(6 am-9:59 pm) \\& every 30 minutes during night(10 pm-5:59 am). ABPM was considered adequate if: number of successful daytime readings were ≥33; number of successful nighttime readings were≥11; no more than 3 hours are not represented(3 sections of 60 minutes with 0 valid readings). To summarize 24-hour ABPM, hourly adjusted mean was calculated. Hourly adjusted mean was average blood pressure(BP) for each hour of the day. 24-hour mean was average of the hourly means.', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The mFAS included all randomized participants who received any amount of study drug. Analysis was grouped according to the randomized treatment arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-20', 'size': 7945486, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-03T03:50', 'hasProtocol': True}, {'date': '2024-07-15', 'size': 4366783, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-03T03:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 663}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2024-09-12', 'completionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2021-10-22', 'resultsFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2021-10-22', 'dispFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-06-19', 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indapamide: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was the average of the hourly means. Least squares (LS) mean and standard error (SE) were calculated using a mixed model repeated measures (MMRM) approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Amlodipine: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was the average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Olmesartan: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during day (6 am- 9:59 pm) and every 30 minutes during night (10 pm-5:59 am). ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e.,3 sections of 60 minutes where 0 valid readings were obtained). To summarize 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}], 'secondaryOutcomes': [{'measure': 'Indapamide: Change From Baseline at Month 3 in Office SBP - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the area under the curve (AUC) of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.'}, {'measure': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.'}, {'measure': 'Indapamide: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6', 'timeFrame': 'Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.'}, {'measure': 'Indapamide: Change From Baseline at Month 3 in 24-hour Mean Diastolic Blood Pressure (DBP), Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Indapamide: Change From Baseline at Month 3 in Office DBP - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.'}, {'measure': 'Indapamide: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Indapamide: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Indapamide: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline and Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.'}, {'measure': 'Indapamide: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data', 'timeFrame': 'Baseline and Month 6', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.'}, {'measure': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.'}, {'measure': 'Indapamide: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.'}, {'measure': 'Indapamide: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data', 'timeFrame': 'Baseline, and Month 2, 3 and 6', 'description': 'ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.'}, {'measure': 'Indapamide: Percent Change From Baseline in Serum Angiotensinogen (AGT)', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6'}, {'measure': 'Amlodipine: Change From Baseline at Month 3 in Office SBP - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.'}, {'measure': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.'}, {'measure': 'Amlodipine: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6', 'timeFrame': 'Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.'}, {'measure': 'Amlodipine: Change From Baseline at Month 3 in 24-hour Mean DBP, Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Amlodipine: Change From Baseline at Month 3 in Office DBP - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.'}, {'measure': 'Amlodipine: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Amlodipine: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Amlodipine: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline and Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.'}, {'measure': 'Amlodipine: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data', 'timeFrame': 'Baseline and Month 6', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.'}, {'measure': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.'}, {'measure': 'Amlodipine: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.'}, {'measure': 'Amlodipine: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data', 'timeFrame': 'Baseline, and Month 2, 3 and 6', 'description': 'ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.'}, {'measure': 'Amlodipine: Percent Change From Baseline in Serum AGT', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6'}, {'measure': 'Olmesartan: Change From Baseline at Month 3 in Office SBP - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.'}, {'measure': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in Office SBP - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP were included in the analysis for this endpoint.'}, {'measure': 'Olmesartan: Percentage of Participants With 24-hour Mean SBP <130 mmHg and/or Reduction From Baseline ≥20 mmHg Assessed by ABPM Without Escape Antihypertensive Medications at Month 6', 'timeFrame': 'Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average of BP for each hour of the day. The 24-hour mean was average of the hourly means.'}, {'measure': 'Olmesartan: Change From Baseline at Month 3 in 24-hour Mean DBP, Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for DBP assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Olmesartan: Change From Baseline at Month 3 in Office DBP - Censored Data', 'timeFrame': 'Baseline and Month 3', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office DBP assessed while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.'}, {'measure': 'Olmesartan: Time-adjusted Change From Baseline Through Month 3 in 24-hour Mean SBP and DBP, Assessed by ABPM - Censored Data', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for SBP and DBP, assessed using ABPM, while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.'}, {'measure': 'Olmesartan: Time-adjusted Change From Baseline in Office SBP and DBP Through Month 3 - Censored Data', 'timeFrame': 'Baseline through Month 3', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Hypothetical strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., data for office SBP and DBP, while participants were on and within 2 weeks after stopping any escape medication was censored for this endpoint.'}, {'measure': 'Olmesartan: Change From Baseline at Month 6 in 24-hour Mean SBP and DBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline and Month 6', 'description': '24-hour ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly adjusted mean was the average BP for each hour of the day. The 24-hour mean was average of the hourly means. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for SBP and DBP assessed by ABPM are included in the analysis for this endpoint.'}, {'measure': 'Olmesartan: Change From Baseline at Month 6 in Office SBP and DBP - All Collected Data', 'timeFrame': 'Baseline and Month 6', 'description': 'The mean office BP in the sitting position was used for the analysis. Office BP in the sitting position was collected with a set of 4 replicates. The average of the last 3 replicates was calculated and used for analysis. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office SBP and DBP, were included in the analysis for this endpoint.'}, {'measure': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in 24-hour Mean DBP, Assessed by ABPM - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for DBP assessed by ABPM were included in the analysis for this endpoint.'}, {'measure': 'Olmesartan: Time-adjusted Change From Baseline Through Month 6 in Office DBP - All Collected Data', 'timeFrame': 'Baseline through Month 6', 'description': 'Time-adjusted change was defined as the AUC of BP change from baseline divided by the duration of the time period. LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for office DBP were included in the analysis for this endpoint.'}, {'measure': 'Olmesartan: Change From Baseline in Daytime and Nighttime SBP and DBP by ABPM at Each Visit - All Collected Data', 'timeFrame': 'Baseline, and Month 2, 3 and 6', 'description': 'ABPM device was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33; 2. the number of successful nighttime readings were ≥11; and 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). LS mean and SE were calculated using a MMRM approach. Treatment policy strategy was used for the intercurrent event of using antihypertensive escape medication, i.e., all collected data for daytime and nighttime SBP and DBP, assessed by ABPM, were included in the analysis for this endpoint.'}, {'measure': 'Olmesartan: Percent Change From Baseline in Serum AGT', 'timeFrame': 'Baseline, Week 2 and Months 1, 2, 3, 4, 5 and 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High blood pressure', 'Hypertension', 'Hypertensive', 'siRNA', 'Angiotensinogen', 'AGT'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '40434761', 'type': 'DERIVED', 'citation': 'Desai AS, Karns AD, Badariene J, Aswad A, Neutel JM, Kazi F, Park W, Stiglitz D, Makarova N, Havasi A, Zappe DH, Saxena M; KARDIA-2 Study Group. Add-On Treatment With Zilebesiran for Inadequately Controlled Hypertension: The KARDIA-2 Randomized Clinical Trial. JAMA. 2025 Jul 1;334(1):46-55. doi: 10.1001/jama.2025.6681.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of zilebesiran on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of zilebesiran as add-on therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Office SBP at Screening as follows:\n\n 1. ≥155 mmHg and ≤180 mmHg for patients with untreated hypertension\n 2. ≥145 mmHg and ≤180 mmHg for patients on antihypertensive medications\n* 24-hour mean SBP ≥130 mmHg and ≤160 mmHg by ABPM after at least 4 weeks of run-in\n\nExclusion Criteria:\n\n* Secondary hypertension, orthostatic hypotension\n* Elevated potassium \\<lower limit of normal (LLN) range or \\>5 milliequivalents per liter (mEq/L)\n* Estimated glomerular filtration rate (eGFR) of \\<30 mL/min/1.73m\\^2\n* Received an investigational agent within the last 30 days\n* Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, or laboratory evidence of diabetes during screening without known diagnosis of diabetes\n* History of any cardiovascular event within 6 months prior to randomization\n* History of intolerance to SC injection(s)'}, 'identificationModule': {'nctId': 'NCT05103332', 'acronym': 'KARDIA-2', 'briefTitle': 'Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication', 'orgStudyIdInfo': {'id': 'ALN-AGT01-003'}, 'secondaryIdInfos': [{'id': '2021-003776-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Add-on to Indapamide)', 'description': 'Following a 4-week run-in treatment on indapamide, 2.5 milligrams (mg), orally, once daily (QD), eligible participants were randomized to receive placebo matched to zilebesiran as a subcutaneous (SC) injection on Day 1 of 6-month double-blind (DB) treatment period as add-on therapy to indapamide. Participants received protocol-assigned background medication for 6 months, after which it was discontinued. Thereafter, participants will receive zilebesiran once every 6 months (Q6M) during the open-label extension (OLE) period. Upon implementation of Amendment 3, the OLE period was closed.', 'interventionNames': ['Drug: Indapamide', 'Drug: Placebo', 'Drug: Zilebesiran']}, {'type': 'EXPERIMENTAL', 'label': 'Zilebesiran (Add-on to Indapamide)', 'description': 'Following a 4-week run-in treatment on indapamide, 2.5 mg, orally, QD, eligible participants were randomized to receive zilebesiran 600 mg, as a SC injection on Day 1 of 6-month DB treatment period as add-on therapy to indapamide. Participants received protocol-assigned background medication for 6 months, after which it was discontinued. Thereafter, participants will receive zilebesiran, Q6M during the OLE period. Upon implementation of Amendment 3, the OLE period was closed.', 'interventionNames': ['Drug: Indapamide', 'Drug: Zilebesiran']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Add-on to Amlodipine)', 'description': 'Following a 4-week run-in treatment on amlodipine, 5 mg, orally, QD, eligible participants were randomized to receive placebo matched to zilebesiran as a SC injection on Day 1 of 6-month DB treatment period as add-on therapy to amlodipine. Participants received protocol-assigned background medication for 6 months, after which it was discontinued. Thereafter, participants will receive zilebesiran Q6M during the OLE period. Upon implementation of Amendment 3, the OLE period was closed.', 'interventionNames': ['Drug: Amlodipine', 'Drug: Placebo', 'Drug: Zilebesiran']}, {'type': 'EXPERIMENTAL', 'label': 'Zilebesiran (Add-on to Amlodipine)', 'description': 'Following a 4-week run-in treatment on amlodipine, 5 mg, orally, QD, eligible participants were randomized to receive zilebesiran 600 mg, as a SC injection on Day 1 of 6-month DB treatment period as add-on therapy to amlodipine. Participants received protocol-assigned background medication for 6 months, after which it was discontinued. Thereafter, participants will receive zilebesiran, Q6M during the OLE period. Upon implementation of Amendment 3, the OLE period was closed.', 'interventionNames': ['Drug: Amlodipine', 'Drug: Zilebesiran']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Add-on to Olmesartan)', 'description': 'Following a 4-week run-in treatment on olmesartan, 40 mg, orally, QD, (or 20 mg, orally, QD for participants with creatinine clearance ≤60 milliliters per minute \\[mL/min\\] at screening enrolled at sites outside of the United States \\[US\\] consistent with local labeling), eligible participants were randomized to receive placebo matched to zilebesiran as a SC injection on Day 1 of 6-month DB treatment period as add-on therapy to olmesartan. Participants received protocol-assigned background medication for 6 months, after which it was discontinued. Thereafter, participants will receive zilebesiran Q6M during the OLE period. Upon implementation of Amendment 3, the OLE period was closed.', 'interventionNames': ['Drug: Olmesartan', 'Drug: Placebo', 'Drug: Zilebesiran']}, {'type': 'EXPERIMENTAL', 'label': 'Zilebesiran (Add-on to Olmesartan)', 'description': 'Following a 4-week run-in treatment on olmesartan, 40 mg, orally, QD, (or 20 mg, orally, QD for participants with creatinine clearance ≤60 mL/min at screening enrolled at sites outside of the US consistent with local labeling), eligible participants were randomized to receive zilebesiran 600 mg, as a SC injection on Day 1 of 6-month DB treatment period as add-on therapy to olmesartan. Participants received protocol-assigned background medication for 6 months, after which it was discontinued. Thereafter, participants will receive zilebesiran, Q6M during the OLE period. Upon implementation of Amendment 3, the OLE period was closed.', 'interventionNames': ['Drug: Olmesartan', 'Drug: Zilebesiran']}], 'interventions': [{'name': 'Indapamide', 'type': 'DRUG', 'description': 'Indapamide administered orally', 'armGroupLabels': ['Placebo (Add-on to Indapamide)', 'Zilebesiran (Add-on to Indapamide)']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine administered orally', 'armGroupLabels': ['Placebo (Add-on to Amlodipine)', 'Zilebesiran (Add-on to Amlodipine)']}, {'name': 'Olmesartan', 'type': 'DRUG', 'description': 'Olmesartan administered orally', 'armGroupLabels': ['Placebo (Add-on to Olmesartan)', 'Zilebesiran (Add-on to Olmesartan)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered by SC injection', 'armGroupLabels': ['Placebo (Add-on to Amlodipine)', 'Placebo (Add-on to Indapamide)', 'Placebo (Add-on to Olmesartan)']}, {'name': 'Zilebesiran', 'type': 'DRUG', 'otherNames': ['ALN-AGT01'], 'description': 'Zilebesiran administered by SC injection', 'armGroupLabels': ['Placebo (Add-on to Amlodipine)', 'Placebo (Add-on to Indapamide)', 'Placebo (Add-on to Olmesartan)', 'Zilebesiran (Add-on to Amlodipine)', 'Zilebesiran (Add-on to Indapamide)', 'Zilebesiran (Add-on to Olmesartan)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.96529, 'lon': 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