Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT04518293
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2020-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D007190', 'term': 'Indapamide'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arodgers@georgeinstitute.org', 'phone': '+44-7983 578 290', 'title': 'Anthony Rogers (Principal Investigator)', 'organization': 'George Medicines Pty Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial included comparatively few participants with very high levels of blood pressure (BP), which makes direct comparison with previous trials challenging. The trial design did not allow a direct randomized comparison between ½ dose and standard dose combinations, or with other drugs and doses that are in common use. The option of non-uptitration after 6 weeks of half-dose regimens likely led to underestimation of the difference between standard dose regimens.'}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'description': 'The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Not Randomized', 'description': 'Participants who were run-in failure and were not randomized (most common reason being home seated mean SBP of 120-154 mmHg in week prior to randomization visit and other reason).', 'otherNumAtRisk': 859, 'deathsNumAtRisk': 859, 'otherNumAffected': 136, 'seriousNumAtRisk': 859, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill', 'otherNumAtRisk': 551, 'deathsNumAtRisk': 551, 'otherNumAffected': 306, 'seriousNumAtRisk': 551, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 282, 'otherNumAffected': 139, 'seriousNumAtRisk': 282, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet', 'otherNumAtRisk': 276, 'deathsNumAtRisk': 276, 'otherNumAffected': 142, 'seriousNumAtRisk': 276, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG004', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet', 'otherNumAtRisk': 276, 'deathsNumAtRisk': 276, 'otherNumAffected': 136, 'seriousNumAtRisk': 276, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lipids increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Glomerular filtration rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Retroperitoneal fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lacrimal gland abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthritis reactive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 859, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 276, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0.2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.44', 'ciLowerLimit': '-6.774', 'ciUpperLimit': '-4.107', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.680', 'groupDescription': 'The LS means (LSM) difference (95% CI) in home seated SBP reduction was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'MIANALYZE procedure', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 12 was estimated using a mixed model for repeated measures (MMRM).'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.49', 'ciLowerLimit': '-3.723', 'ciUpperLimit': '-1.251', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.630', 'groupDescription': 'The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'MIANALYZE procedure', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.42', 'ciLowerLimit': '-5.758', 'ciUpperLimit': '-3.091', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.680', 'groupDescription': 'The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'MIANALYZE procedure', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.02', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '0.86', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.60', 'ciLowerLimit': '-7.307', 'ciUpperLimit': '-3.902', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.863', 'groupDescription': 'The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 between dual-TA arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 12 was estimated using a MMRM.'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.33', 'ciLowerLimit': '-6.718', 'ciUpperLimit': '-1.933', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.212', 'groupDescription': 'The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.33', 'ciLowerLimit': '-7.984', 'ciUpperLimit': '-4.680', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.837', 'groupDescription': 'The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '1.02', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.01', 'ciLowerLimit': '-6.703', 'ciUpperLimit': '-3.317', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.858', 'groupDescription': 'The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.50', 'ciLowerLimit': '-5.293', 'ciUpperLimit': '-1.700', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.910', 'groupDescription': 'The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.35', 'ciLowerLimit': '-7.251', 'ciUpperLimit': '-3.444', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.965', 'groupDescription': 'The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6', 'description': 'Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. 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Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. 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Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. 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Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. 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Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. 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Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.45', 'ciLowerLimit': '3.993', 'ciUpperLimit': '16.433', 'groupDescription': 'The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.93', 'ciLowerLimit': '2.337', 'ciUpperLimit': '15.058', 'groupDescription': 'The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.19', 'ciLowerLimit': '5.792', 'ciUpperLimit': '18.073', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The percentage of participants achieving averaged clinic SBP \\<130 mmHg and DBP \\<80 mmHg at Week 6 was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '0.56', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.11', 'ciLowerLimit': '-7.086', 'ciUpperLimit': '-5.144', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.495', 'groupDescription': 'The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.00', 'ciLowerLimit': '-4.060', 'ciUpperLimit': '-1.932', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.543', 'groupDescription': 'The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.09', 'ciLowerLimit': '-6.274', 'ciUpperLimit': '-3.912', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.603', 'groupDescription': 'The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6', 'description': 'Difference in change in average home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.45', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.35', 'ciLowerLimit': '-4.069', 'ciUpperLimit': '-2.632', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.364', 'groupDescription': 'The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-2.998', 'ciUpperLimit': '-1.200', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.456', 'groupDescription': 'The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.63', 'ciLowerLimit': '-4.617', 'ciUpperLimit': '-2.649', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.499', 'groupDescription': 'The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.40', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '0.41', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.52', 'ciLowerLimit': '-4.137', 'ciUpperLimit': '-2.908', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.311', 'groupDescription': 'The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.09', 'ciLowerLimit': '-2.803', 'ciUpperLimit': '-1.376', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.361', 'groupDescription': 'The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.58', 'ciLowerLimit': '-4.446', 'ciUpperLimit': '-2.713', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.439', 'groupDescription': 'The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6', 'description': 'Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.63', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.58', 'ciLowerLimit': '-6.983', 'ciUpperLimit': '-4.169', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.713', 'groupDescription': 'The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.'}, {'pValue': '0.0043', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.91', 'ciLowerLimit': '-3.218', 'ciUpperLimit': '-0.607', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.662', 'groupDescription': 'The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.74', 'ciLowerLimit': '-5.214', 'ciUpperLimit': '-2.274', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.745', 'groupDescription': 'The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12. Trough values were measured before morning dose of the study medication.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.57', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.25', 'ciLowerLimit': '-7.324', 'ciUpperLimit': '-5.168', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.546', 'groupDescription': 'The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.72', 'ciLowerLimit': '-3.941', 'ciUpperLimit': '-1.507', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.616', 'groupDescription': 'The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.43', 'ciLowerLimit': '-5.489', 'ciUpperLimit': '-3.368', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.537', 'groupDescription': 'The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 6', 'description': 'Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. Trough values were measured before morning dose of the study medication.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '155', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.79', 'ciLowerLimit': '7.749', 'ciUpperLimit': '21.824', 'groupDescription': 'The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0146', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.46', 'ciLowerLimit': '1.580', 'ciUpperLimit': '15.501', 'groupDescription': 'The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.07', 'ciLowerLimit': '8.953', 'ciUpperLimit': '23.171', 'groupDescription': 'The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The percentage of participants achieving averaged home SBP \\<135 mmHg and DBP \\<85 mmHg at week 12 was calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '346', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.11', 'ciLowerLimit': '10.778', 'ciUpperLimit': '25.226', 'groupDescription': 'The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0674', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.64', 'ciLowerLimit': '-0.613', 'ciUpperLimit': '13.926', 'groupDescription': 'The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.23', 'ciLowerLimit': '10.839', 'ciUpperLimit': '25.392', 'groupDescription': 'The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The percentage of participants achieving averaged home SBP \\<135 mmHg and DBP \\<85 mmHg at Week 6 was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '308', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.25', 'ciLowerLimit': '9.902', 'ciUpperLimit': '24.286', 'groupDescription': 'The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.06', 'ciLowerLimit': '4.632', 'ciUpperLimit': '19.293', 'groupDescription': 'The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.93', 'ciLowerLimit': '15.622', 'ciUpperLimit': '29.796', 'groupDescription': 'The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The percentage of participants achieving averaged home SBP \\<130 mmHg and DBP \\<80 mmHg at Week 12 was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.59', 'ciLowerLimit': '11.579', 'ciUpperLimit': '25.124', 'groupDescription': 'The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.22', 'ciLowerLimit': '4.963', 'ciUpperLimit': '19.123', 'groupDescription': 'The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.20', 'ciLowerLimit': '9.060', 'ciUpperLimit': '22.914', 'groupDescription': 'The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The percentage of participants achieving averaged home SBP \\<130 mmHg and DBP \\<80 mmHg at Week 6 was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '-1.529', 'ciUpperLimit': '2.768', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-2.098', 'ciUpperLimit': '2.475', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-2.098', 'ciUpperLimit': '2.475', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The primary safety outcome is the proportion of participants who discontinued trial medication due to an AE or SAE from randomization to follow-up at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants who discontinued trial medication due to AE/SAE from randomization to follow-up at Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With a Serious Adverse Event (SAE) From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 12', 'description': 'The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serious Adverse Event (SAE) From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Symptomatic Hypotension From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Symptomatic Hypotension From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.07', 'ciLowerLimit': '0.494', 'ciUpperLimit': '7.116', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-3.927', 'ciUpperLimit': '4.020', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.64', 'ciLowerLimit': '-0.070', 'ciUpperLimit': '6.764', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\<135 mmol/L at follow-up Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.59', 'ciLowerLimit': '-0.500', 'ciUpperLimit': '5.136', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '-1.513', 'ciUpperLimit': '4.517', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '-2.855', 'ciUpperLimit': '3.633', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\<135 mmol/L at follow-up Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-3.911', 'ciUpperLimit': '3.129', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-4.519', 'ciUpperLimit': '2.744', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-3.228', 'ciUpperLimit': '3.647', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\>145 mmol/L at follow-up Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-3.993', 'ciUpperLimit': '2.816', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '-1.513', 'ciUpperLimit': '4.517', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-4.596', 'ciUpperLimit': '2.440', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\>145 mmol/L at follow-up Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.72', 'ciLowerLimit': '4.196', 'ciUpperLimit': '9.222', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '-1.883', 'ciUpperLimit': '5.257', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.97', 'ciLowerLimit': '-10.979', 'ciUpperLimit': '-1.600', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum potassium concentration \\<3.5 mmol/L at follow-up Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.13', 'ciLowerLimit': '0.123', 'ciUpperLimit': '5.632', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '-2.245', 'ciUpperLimit': '4.134', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.71', 'ciLowerLimit': '-6.968', 'ciUpperLimit': '0.819', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with serum potassium concentration below 3.5 mmol/l at follow-up Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '-0.863', 'ciUpperLimit': '2.231', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '-0.897', 'ciUpperLimit': '2.231', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-1.494', 'ciUpperLimit': '1.913', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is proportion of participants with serum potassium concentration \\>5.5 mmol/l at follow-up Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-1.931', 'ciUpperLimit': '1.149', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-1.979', 'ciUpperLimit': '1.143', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '-1.374', 'ciUpperLimit': '1.453', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is proportion of participants with serum potassium concentration \\>5.5 mmol/L at follow-up Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-2.014', 'ciUpperLimit': '2.087', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '-1.015', 'ciUpperLimit': '2.633', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '-1.015', 'ciUpperLimit': '2.633', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome was the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-2.501', 'ciUpperLimit': '1.385', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-3.078', 'ciUpperLimit': '1.108', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-2.571', 'ciUpperLimit': '1.370', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Sodium <135mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5mmol/L at Follow-up Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.55', 'ciLowerLimit': '5.422', 'ciUpperLimit': '15.138', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.11', 'ciLowerLimit': '-2.776', 'ciUpperLimit': '8.490', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.60', 'ciLowerLimit': '-7.807', 'ciUpperLimit': '4.174', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at follow-up Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serum Sodium <135 mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5 mmol/L at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.47', 'ciLowerLimit': '0.531', 'ciUpperLimit': '9.867', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TA arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.92', 'ciLowerLimit': '-0.136', 'ciUpperLimit': '9.397', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.60', 'ciLowerLimit': '-7.299', 'ciUpperLimit': '3.567', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-AI arms.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is proportion of participants with serum sodium \\<135 mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5 mmol/L at follow-up Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Orthostatic Hypotension at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9677', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-3.825', 'ciUpperLimit': '3.019', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'pValue': '0.1952', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.35', 'ciLowerLimit': '-6.550', 'ciUpperLimit': '1.125', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7453', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-4.428', 'ciUpperLimit': '2.642', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Orthostatic Hypotension at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9415', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-3.657', 'ciUpperLimit': '3.222', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'pValue': '0.1719', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.53', 'ciLowerLimit': '-6.799', 'ciUpperLimit': '1.019', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2342', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.16', 'ciLowerLimit': '-6.380', 'ciUpperLimit': '1.326', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Orthostatic Hypertension at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.87', 'ciLowerLimit': '-9.316', 'ciUpperLimit': '3.215', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'pValue': '0.7529', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '-5.356', 'ciUpperLimit': '6.800', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'pValue': '0.4563', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.32', 'ciLowerLimit': '-8.791', 'ciUpperLimit': '3.772', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Orthostatic Hypertension at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'OG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'OG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'OG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9691', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-6.063', 'ciUpperLimit': '5.859', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TA arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'pValue': '0.2454', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.59', 'ciLowerLimit': '-10.018', 'ciUpperLimit': '2.462', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}, {'pValue': '0.9130', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-6.583', 'ciUpperLimit': '5.488', 'groupDescription': 'The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-AI arms.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '95% CI for risk difference utilized Newcombe estimation method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'FG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg . At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg .: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'FG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'FG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}], 'periods': [{'title': 'Single, Active run-in (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A total of 2,244 screened participants entered in the GMRx2 run-in treatment period, during which participants were all switched from existing regimens to GMRx2 Dose 2.', 'groupId': 'FG000', 'numSubjects': '2244'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Enrolled participants completed single-blind active run-in period on GMRx2 and were subsequently randomized to blinded treatment arms.', 'achievements': [{'comment': 'Following run-in, 1385 participants were randomized with a 2:1:1:1 ratio of GMRx2: Dual-TA: Dual-TI: Dual-AI during the double-blind period.', 'groupId': 'FG000', 'numSubjects': '1385'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '859'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Double-blind', 'milestones': [{'type': 'STARTED', 'comment': 'Enrolled patients completed screening and unblinded active run-in on GMRx2, and were subsequently randomised to a blinded treatment arm.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '551'}, {'groupId': 'FG001', 'numSubjects': '282'}, {'groupId': 'FG002', 'numSubjects': '276'}, {'groupId': 'FG003', 'numSubjects': '276'}]}, {'type': 'COMPLETED', 'comment': 'Completion of trial is defined as attending Week 12/Visit Follow-Up 2 and Week 16/Visit End of Trial.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '273'}, {'groupId': 'FG002', 'numSubjects': '259'}, {'groupId': 'FG003', 'numSubjects': '259'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'This trial was conducted at 83 study centers across 7 countries (Australia \\[6\\], Czech Republic \\[2\\], Great Britain \\[25\\], New Zealand \\[2\\], Poland \\[9\\], Sri Lanka \\[14\\], and USA \\[25\\]).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill\n\ntelmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill'}, {'id': 'BG001', 'title': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg\n\nTelmisartan 20 mg/amlodipine 2.5 mg: oral tablet\n\ntelmisartan 40 mg/amlodipine 5 mg: oral tablet'}, {'id': 'BG002', 'title': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg\n\nTelmisartan 20 mg/indapamide 1.25 mg: oral tablet\n\ntelmisartan 40 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'BG003', 'title': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg\n\nAmlodipine 2.5 mg/indapamide 1.25 mg: oral tablet\n\namlodipine 5 mg/indapamide 2.5 mg: oral tablet'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '59.1', 'spread': '11.28', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '11.41', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '10.29', 'groupId': 'BG002'}, {'value': '58.9', 'spread': '11.32', 'groupId': 'BG003'}, {'value': '59.0', 'spread': '11.12', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '148', 'groupId': 'BG003'}, {'value': '712', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}, {'value': '673', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '159', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '487', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG003'}, {'value': '1224', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '673', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}, {'value': '631', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}]}, {'title': 'Sri Lanka', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '646', 'groupId': 'BG004'}]}]}, {'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '351', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1375', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '28.87', 'spread': '5.688', 'groupId': 'BG000'}, {'value': '28.68', 'spread': '5.735', 'groupId': 'BG001'}, {'value': '29.05', 'spread': '5.686', 'groupId': 'BG002'}, {'value': '28.82', 'spread': '6.022', 'groupId': 'BG003'}, {'value': '28.86', 'spread': '5.761', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data on BMI was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1375', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '79.09', 'spread': '20.714', 'groupId': 'BG000'}, {'value': '78.19', 'spread': '19.995', 'groupId': 'BG001'}, {'value': '79.38', 'spread': '20.623', 'groupId': 'BG002'}, {'value': '78.03', 'spread': '20.859', 'groupId': 'BG003'}, {'value': '78.75', 'spread': '20.565', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data on weight was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '545', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1375', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '164.72', 'spread': '11.054', 'groupId': 'BG000'}, {'value': '164.47', 'spread': '10.659', 'groupId': 'BG001'}, {'value': '164.54', 'spread': '11.566', 'groupId': 'BG002'}, {'value': '163.84', 'spread': '11.702', 'groupId': 'BG003'}, {'value': '164.46', 'spread': '11.204', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data on height was reported for 545, 281 and 273 participants for GMRx2, dual-TA and dual-TI groups.'}, {'title': 'Smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '431', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '1047', 'groupId': 'BG004'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '266', 'groupId': 'BG004'}]}, {'title': 'Current smoker', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Currently drink alcohol once a week or more', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '481', 'groupId': 'BG004'}]}, {'title': 'Not currently drinking', 'measurements': [{'value': '372', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}, {'value': '904', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-Screening 12-Lead ECG', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '210', 'groupId': 'BG003'}, {'value': '1041', 'groupId': 'BG004'}]}, {'title': 'Atrial fibrillation', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Any other abnormalities', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '277', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension Status at Screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Office BP<140/90 mmHg', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '489', 'groupId': 'BG004'}]}, {'title': 'Office BP≥140/90 mmHg', 'measurements': [{'value': '354', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}, {'value': '896', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Prior BP Treatments at Screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}, {'value': '1385', 'groupId': 'BG004'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '144', 'groupId': 'BG004'}]}, {'title': '1', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '473', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}, {'value': '555', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '213', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-10', 'size': 2844113, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-02T21:41', 'hasProtocol': True}, {'date': '2023-11-18', 'size': 1329165, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-02T21:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'International, multicenter, randomized, double-blind, active-controlled, parallel group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1385}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2020-08-15', 'resultsFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2020-08-15', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-14', 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'The primary safety outcome is the proportion of participants who discontinued trial medication due to an AE or SAE from randomization to follow-up at Week 12.'}, {'measure': 'Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants who discontinued trial medication due to AE/SAE from randomization to follow-up at Week 6.'}, {'measure': 'Percentage of Participants With a Serious Adverse Event (SAE) From Randomization to Week 12', 'timeFrame': 'At Week 12', 'description': 'The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 12.'}, {'measure': 'Percentage of Participants With Serious Adverse Event (SAE) From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 6.'}, {'measure': 'Percentage of Participants With Symptomatic Hypotension From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 12.'}, {'measure': 'Percentage of Participants With Symptomatic Hypotension From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 6.'}, {'measure': 'Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\<135 mmol/L at follow-up Week 12.'}, {'measure': 'Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\<135 mmol/L at follow-up Week 6.'}, {'measure': 'Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\>145 mmol/L at follow-up Week 12.'}, {'measure': 'Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\>145 mmol/L at follow-up Week 6.'}, {'measure': 'Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum potassium concentration \\<3.5 mmol/L at follow-up Week 12.'}, {'measure': 'Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with serum potassium concentration below 3.5 mmol/l at follow-up Week 6.'}, {'measure': 'Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is proportion of participants with serum potassium concentration \\>5.5 mmol/l at follow-up Week 12.'}, {'measure': 'Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is proportion of participants with serum potassium concentration \\>5.5 mmol/L at follow-up Week 6.'}, {'measure': 'Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome was the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 12.'}, {'measure': 'Percentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 6.'}, {'measure': 'Percentage of Participants With Serum Sodium <135mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5mmol/L at Follow-up Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with serum sodium \\<135mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5mmol/L at follow-up Week 12.'}, {'measure': 'Percentage of Participants With Serum Sodium <135 mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5 mmol/L at Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is proportion of participants with serum sodium \\<135 mmol/L or \\>145 mmol/L, and/or serum potassium \\<3.5 mmol/L or \\>5.5 mmol/L at follow-up Week 6.'}, {'measure': 'Percentage of Participants With Orthostatic Hypotension at Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 6.'}, {'measure': 'Percentage of Participants With Orthostatic Hypotension at Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 12.'}, {'measure': 'Percentage of Participants With Orthostatic Hypertension at Week 6', 'timeFrame': 'Week 6', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 6.'}, {'measure': 'Percentage of Participants With Orthostatic Hypertension at Week 12', 'timeFrame': 'Week 12', 'description': 'The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 12.'}], 'primaryOutcomes': [{'measure': 'Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.'}], 'secondaryOutcomes': [{'measure': 'Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.'}, {'measure': 'Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.'}, {'measure': 'Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.'}, {'measure': 'Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.'}, {'measure': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'The percentage of participants achieving averaged clinic SBP \\<140 mmHg and DBP \\<90 mmHg at Week 12 was evaluated.'}, {'measure': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6', 'timeFrame': 'Week 6', 'description': 'The percentage of participants achieving averaged clinic SBP \\<140 mmHg and DBP \\<80 mmHg at Week 6 was evaluated.'}, {'measure': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'The percentage of participants achieving averaged clinic SBP \\<130 mmHg and DBP \\<80 mmHg at Week 12 was evaluated.'}, {'measure': 'Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6', 'timeFrame': 'Week 6', 'description': 'The percentage of participants achieving averaged clinic SBP \\<130 mmHg and DBP \\<80 mmHg at Week 6 was evaluated.'}, {'measure': 'Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'Difference in change in average home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.'}, {'measure': 'Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.'}, {'measure': 'Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.'}, {'measure': 'Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12', 'timeFrame': 'Week 12', 'description': 'Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12. Trough values were measured before morning dose of the study medication.'}, {'measure': 'Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6', 'timeFrame': 'Week 6', 'description': 'Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. Trough values were measured before morning dose of the study medication.'}, {'measure': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'The percentage of participants achieving averaged home SBP \\<135 mmHg and DBP \\<85 mmHg at week 12 was calculated.'}, {'measure': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 6', 'timeFrame': 'Week 6', 'description': 'The percentage of participants achieving averaged home SBP \\<135 mmHg and DBP \\<85 mmHg at Week 6 was evaluated.'}, {'measure': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12', 'timeFrame': 'Week 12', 'description': 'The percentage of participants achieving averaged home SBP \\<130 mmHg and DBP \\<80 mmHg at Week 12 was evaluated.'}, {'measure': 'Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6', 'timeFrame': 'Week 6', 'description': 'The percentage of participants achieving averaged home SBP \\<130 mmHg and DBP \\<80 mmHg at Week 6 was evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '39426836', 'type': 'DERIVED', 'citation': 'Rodgers A, Salam A, Schutte AE, Cushman WC, de Silva HA, Di Tanna GL, Grobbee DE, Narkiewicz K, Ojji DB, Poulter NR, Schlaich MP, Oparil S, Spiering W, Williams B, Wright JT Jr, Lakshman P, Uluwattage W, Hay P, Pereira T, Amarasena N, Ranasinghe G, Gianacas C, Shanthakumar M, Liu X, Wang N, Gnanenthiran SR, Whelton PK; GMRx2 Investigators. Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial. Lancet. 2024 Oct 19;404(10462):1536-1546. doi: 10.1016/S0140-6736(24)01744-6.'}]}, 'descriptionModule': {'briefSummary': 'Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure (BP) control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.', 'detailedDescription': 'TRIAL DRUG:\n\nGMRx2: Single pill combinations of telmisartan/amlodipine/indapamide Dose version 2: telmisartan 20mg/amlodipine 2.5mg/indapamide 1.25mg Dose version 3: telmisartan 40mg/amlodipine 5 mg/indapamide 2.5mg INDICATION: Hypertension TRIAL DESIGN: International, multicenter, randomized, double-blind, active controlled, parallel-group.\n\nOBJECTIVES: To investigate the efficacy and safety of GMRx2 compared to dual combinations\n\nINTERVENTION:\n\nSingle-Blind Active Run-In Period. Enrolled participants will be asked to discontinue their current BP-lowering drug(s) and undergo a single-blind active run-in period for 4 weeks with GMRx2 dose version 2. Participants will be advised to take the capsule once daily in the morning at approximately the same time each day. For days on which BP is being measured, the capsule should be taken directly after the morning home BP measurement.\n\nDouble-Blind Treatment Period. Participants still eligible after the run-in period will be allocated in a double-blind fashion to one of the following 4 randomized groups: GMRx2 dose version 2, or telmisartan 20mg+amlodipine2.5mg, or telmisartan 20mg+indapamide 1.25mg, or amlodipine 2.5mg+indapamide 1.25mg. At week 6 all doses will be doubled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAt screening visit\n\n1. Provided signed consent to participate in the trial.\n2. Adult of age ≥18 years.\n3. Attended automated clinic seated mean systolic blood pressure (SBP) (average of last 2 measurements calculated by the device):\n\n140-179 mmHg on 0 BP-lowering drugs, or 130-170 mmHg on 1 BP-lowering drug, or 120-160 mmHg on 2 BP-lowering drugs, or 110-150 mmHg on 3 BP-lowering drugs.\n\nAt randomization visit\n\n1. Home seated mean SBP 110-154 mmHg in the week prior to the randomization visit.\n2. Adherence of 80-120% to run-in medication.\n3. Tolerated run-in medication.\n4. Adherence to home BP monitoring schedule: in the week before randomization, at least 6 measures (e.g. ≥2 sets of triplicate measures, ≥3 sets of duplicate measures) including at least 1 morning and 1 evening each with ≥2 measures. Morning is defined as any measure in the am and evening as any measure in the pm. Morning and evening do not have to be same day.\n\nExclusion Criteria:\n\nAt screening visit\n\n1. Receiving 4 or more BP-lowering drugs.\n2. Receiving any BP lowering drugs for indications other than hypertension e.g. heart failure\n3. Pregnant or had a positive pregnancy test or unwilling to undertake a pregnancy test during the trial and up to 30 days after the discontinuation of the trial medication or breastfeeding or of childbearing age and not using an acceptable method of contraception. Acceptable methods of birth control include hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g. condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization. Contraception should be used for at least 1 month before the screening visit and until the end of trial participation.\n4. Not suitable for participation in a clinical trial according to local ethical or regulatory requirements related to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).\n5. Contraindication, including hypersensitivity (e.g. anaphylaxis or angioedema), to the active run-in treatment or to any of the trial medication options in the four randomized groups.\n6. Current/history of transient ischemic attack, stroke, or hypertensive encephalopathy.\n7. Current/history of acute coronary syndrome, unstable angina, myocardial infarction, percutaneous transluminal coronary revascularization, or coronary artery bypass graft.\n8. Current atrial fibrillation. Patients with a history of paroxysmal atrial fibrillation are potentially eligible as long as there has been no episode in the last 3 months, while patient with a history of persistent or permanent atrial fibrillation are not eligible.\n9. Current/history of New York Heart Association class III and IV congestive heart failure.\n10. Current/history of a known secondary cause of hypertension, such as primary aldosteronism, renal artery stenosis, pheochromocytoma, or Cushing's syndrome.\n11. Current/history of substantially uncontrolled diabetes (HbA1c \\> 11.0%) within last three months.\n12. Current/history of end-stage renal disease or anuria or estimated glomerular filtration rate (eGFR) \\<60 ml/min/1.73m2.\n13. Electrolyte levels that would be regarded as contraindications for any of the potential treatment arms e.g. serum sodium \\<132mmol/l or \\>148mmol/l serum potassium \\<3.1 mmol/l or \\>5.6 mmol/l.\n14. Current/history of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 times the upper limit of normal range within 6 months.\n15. Current concomitant illness or physical impairment or mental condition that in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants' well-being.\n16. Arm circumference that is too large (\\>55 cm) or too small (\\<15-24 cm) to allow accurate measurement of BP.\n17. Currently taking or might need during the trial, a concomitant treatment which is known to interact with one or more of the trial medications: digoxin, lithium, diabetics receiving aliskiren, moderate and strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, diltiazem\\], simvastatin \\>20 mg/day, immunosuppressants.\n18. Might need treatment with drugs that are prohibited during the trial: other antihypertensive drugs, endothelin receptor antagonists, neprilysin inhibitors, or other drugs that may affect BP.\n19. Current surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of trial drugs such as prior major gastrointestinal tract surgery (e.g. gastrectomy, lap band, or bowel resection) or acute flare of inflammatory bowel disease within one year.\n20. Individuals working \\>2 nightshifts per week.\n21. Participated in any investigative drug or device trial within the previous 30 days.\n22. History of alcohol or drug abuse within 12 months.\n\nAt randomization visit\n\n1. Unable to adhere to the trial procedures during the run-in treatment period.\n2. Any of the following which in the investigator's judgment may compromise the safety of the participant if randomized to the trial medications:\n\n 1. High or low clinic BP levels even in the light of the values for home BP that are available for that participant. The exact levels of BP are not specified, since there is clinical uncertainty as to the relevance of BP levels which are high or low in clinic only; for example, the clinical relevance of 'whitecoat hypertension' is uncertain.\n 2. High or low home diastolic BP (DBP) levels. The exact levels of DBP is not specified, reflecting clinical uncertainty of the implications of isolated diastolic hypertension. However, home DBP values of \\>99 mmHg may typically be considered as requiring treatment intensification, and such participants would not be suitable for randomization.\n 3. Any abnormal laboratory value which in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants' well-being.\n 4. Fulfilling any of the exclusion criteria mentioned for the screening visit, when verified again at randomization visit."}, 'identificationModule': {'nctId': 'NCT04518293', 'acronym': 'GMRx2_ACT', 'briefTitle': 'Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'George Medicines PTY Limited'}, 'officialTitle': 'Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension', 'orgStudyIdInfo': {'id': 'GMRx2-HTN-2020-ACT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GMRx2', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg', 'interventionNames': ['Drug: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg', 'Drug: telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual - TA', 'description': 'Telmisartan 20 mg/amlodipine 2.5 mg . At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg', 'interventionNames': ['Drug: Telmisartan 20 mg/amlodipine 2.5 mg', 'Drug: telmisartan 40 mg/amlodipine 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual - TI', 'description': 'Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg', 'interventionNames': ['Drug: Telmisartan 20 mg/indapamide 1.25 mg', 'Drug: telmisartan 40 mg/indapamide 2.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual - AI', 'description': 'Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg', 'interventionNames': ['Drug: Amlodipine 2.5 mg/indapamide 1.25 mg', 'Drug: amlodipine 5 mg/indapamide 2.5 mg']}], 'interventions': [{'name': 'Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg', 'type': 'DRUG', 'description': 'Single pill', 'armGroupLabels': ['GMRx2']}, {'name': 'telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg', 'type': 'DRUG', 'description': 'Single pill', 'armGroupLabels': ['GMRx2']}, {'name': 'Telmisartan 20 mg/amlodipine 2.5 mg', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Dual - TA']}, {'name': 'telmisartan 40 mg/amlodipine 5 mg', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Dual - TA']}, {'name': 'Telmisartan 20 mg/indapamide 1.25 mg', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Dual - TI']}, {'name': 'telmisartan 40 mg/indapamide 2.5 mg', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Dual - TI']}, {'name': 'Amlodipine 2.5 mg/indapamide 1.25 mg', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Dual - AI']}, {'name': 'amlodipine 5 mg/indapamide 2.5 mg', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['Dual - AI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Headlands Research', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Quality of Life Medical & Research Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90280', 'city': 'South Gate', 'state': 'California', 'country': 'United States', 'facility': 'Valiance Clinical Research', 'geoPoint': {'lat': 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