Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT05137002
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2021-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of CIN-107 in Patients With Uncontrolled Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yhalvorsen@cincor.com', 'phone': '617-675-8126', 'title': 'Yuan-Di Halvorsen', 'organization': 'CinCor Pharma'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo for up to 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).\n\nAfter 8 weeks, patients will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II)', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 5, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CIN-107 0.5 mg', 'description': 'CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).\n\nAfter 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 8, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CIN-107 1 mg', 'description': 'CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).\n\nAfter 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II)', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 6, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'CIN-107 2 mg', 'description': 'CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I).\n\nAfter 8 weeks, patients may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) or withdraw study participation depending on BP control', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 3, 'seriousNumAtRisk': 60, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part II - CIN-107 2 mg', 'description': 'CIN-107: (2mg) CIN-107 tablets by mouth once daily and discontinue their background anti-hypertensive agent(s) for 4 weeks (Part II).', 'otherNumAtRisk': 213, 'deathsNumAtRisk': 213, 'otherNumAffected': 6, 'seriousNumAtRisk': 213, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 213, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Seated Systolic BP (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'OG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.6', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-17.0', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '-16.0', 'spread': '1.62', 'groupId': 'OG002'}, {'value': '-19.8', 'spread': '1.67', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The primary efficacy endpoint was the change from baseline in mean seated SBP after 8 weeks of treatment in patients with uncontrolled HTN (Part 1).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population - Four subjects (1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively) discontinued Part 1 early, but had their early termination (ET) visits within Week 8/Visit 6 analysis visit window.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Seated Diastolic BP (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'OG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '1.19', 'groupId': 'OG002'}, {'value': '-5.4', 'spread': '1.23', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population - Four subjects (1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively) discontinued Part 1 early, but had their early termination (ET) visits within Week 8/Visit 6 analysis visit window.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Urine Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'OG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.90', 'spread': '29.183', 'groupId': 'OG000'}, {'value': '-114.16', 'spread': '31.305', 'groupId': 'OG001'}, {'value': '-140.45', 'spread': '29.999', 'groupId': 'OG002'}, {'value': '-121.64', 'spread': '30.760', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population - Two subjects discontinued Part 1 early, but had their ET measures taken within Week8/Visit 6 analysis visit window: 1 from Placebo and 1 from 0.5mg. In addition, 7 subjects completed Part 1 but either did not have baseline measure or did not have Week 8/Visit 6 measure: 2, 2, 3 subjects from Placebo, 0.5mg CIN 107, and 1mg CIN 107, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Serum Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'OG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.490', 'groupId': 'OG000'}, {'value': '-2.76', 'spread': '0.493', 'groupId': 'OG001'}, {'value': '-2.95', 'spread': '0.508', 'groupId': 'OG002'}, {'value': '-2.92', 'spread': '0.515', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population - Four subjects discontinued Part 1 early, but had their ET measures taken within Week8/Visit 6 analysis visit window: 1, 2, 1 subjects from Placebo, 0.5mg CIN 107, and 2mg CIN 107, respectively. In addition, 13 subjects completed Part 1 but either did not have baseline measure or did not have Week 8/Visit 6 measure: 4, 6, 3 subjects from Placebo, 1mg CIN 107, and 2mg CIN 107, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving a Mean Seated SBP <130 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'OG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'The percentage of patients achieving a mean seated SBP \\<130 mmHg ("responders") with CIN-107 compared to placebo after 8 weeks of treatment (Part 1; Weeks 1 to 8)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population - Patients without a Week 8/Visit 6 systolic blood pressure measure were considered non-responders. So, if a subject was in the mITT Population but discontinued the study early or if SBP measure was unavailable at Week 8, then they were considered non responders and still contributed to the total number of participants used in analyses.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Urine Renin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'OG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.08', 'spread': '16.584', 'groupId': 'OG000'}, {'value': '-6.54', 'spread': '15.739', 'groupId': 'OG001'}, {'value': '-5.74', 'spread': '10.703', 'groupId': 'OG002'}, {'value': '4.11', 'spread': '17.930', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)', 'unitOfMeasure': 'ng/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population - The 24 hour urine renin pharmacodynamic analyte was added in later, with protocol v3.0. Only subjects who had this measured at baseline are included in overall number of participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Serum Renin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'OG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'OG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '92.902', 'spread': '144.3969', 'groupId': 'OG000'}, {'value': '63.565', 'spread': '195.0495', 'groupId': 'OG001'}, {'value': '88.041', 'spread': '91.2996', 'groupId': 'OG002'}, {'value': '-140.961', 'spread': '151.5431', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population - The 24 hour serum renin pharmacodynamic analyte was added in later, with protocol v3.0. Only subjects who had this measured at baseline are included in overall number of participants analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: Placebo tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I).\n\nAfter 8 weeks, patients will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II)'}, {'id': 'FG001', 'title': 'CIN-107 0.5 mg', 'description': 'CIN-107: (0.5mg) CIN-107 tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I).\n\nAfter 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II)'}, {'id': 'FG002', 'title': 'CIN-107 1 mg', 'description': 'CIN-107: (1mg) CIN-107 tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I).\n\nAfter 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II)'}, {'id': 'FG003', 'title': 'CIN-107 2 mg', 'description': 'CIN-107: (2mg) CIN-107 tablets by mouth once daily. IMP is taken as add-on while remaining on background anti-hypersensitive regimen for 8 weeks (Part I).\n\nAfter 8 weeks, patients may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (Part II) or withdraw study participation depending on BP control'}, {'id': 'FG004', 'title': 'Part II - CIN-107 2mg', 'description': 'CIN-107: (2mg) CIN-107 tablets by mouth once daily.\n\nAfter 8 weeks, patients may switch to or remain on 2mg CIN-107 and discontinue their background antihypertensive agent(s) for 4 weeks (Part II).'}], 'periods': [{'title': 'Part I (8 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part II (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'A total of 227 participants completed Part I, but 14 (1 of 0.5mg CIN-107 Part I, 1 of 1mg CIN-107 Part I, and 12 of 2mg CIN-107 Part I) of these participants did not enter Part II, 213 participants entered Part II.', 'groupId': 'FG004', 'numSubjects': '213'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': "A Run-In Period up to 4 weeks before randomization, to confirm the patient's adherence to their background antihypertensive medication(s) and placebo was done. A total of 631 patients were screened for the study, of which 382 (60.5%) patients failed the screening. Two hundred forty-nine patients were randomized to 1 of the 4 treatment groups."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '249', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nPlacebo: Placebo tablets by mouth once daily'}, {'id': 'BG001', 'title': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'BG002', 'title': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'BG003', 'title': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control\n\nCIN-107: CIN-107 tablets by mouth once daily'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '10.61', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '10.85', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '10.69', 'groupId': 'BG002'}, {'value': '59.2', 'spread': '11.88', 'groupId': 'BG003'}, {'value': '60.2', 'spread': '10.96', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '133', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '116', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '249', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Seated SBP', 'classes': [{'categories': [{'measurements': [{'value': '147.9', 'spread': '9.33', 'groupId': 'BG000'}, {'value': '146.3', 'spread': '8.60', 'groupId': 'BG001'}, {'value': '147.0', 'spread': '9.07', 'groupId': 'BG002'}, {'value': '146.3', 'spread': '7.83', 'groupId': 'BG003'}, {'value': '146.9', 'spread': '8.71', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-25', 'size': 12577785, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-30T08:05', 'hasProtocol': True}, {'date': '2022-10-07', 'size': 7008631, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-30T08:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-28', 'studyFirstSubmitDate': '2021-11-16', 'resultsFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-28', 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Seated Systolic BP (SBP)', 'timeFrame': '8 weeks', 'description': 'The primary efficacy endpoint was the change from baseline in mean seated SBP after 8 weeks of treatment in patients with uncontrolled HTN (Part 1).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Seated Diastolic BP (DBP)', 'timeFrame': '8 weeks', 'description': 'The change from baseline in mean seated DBP with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)'}, {'measure': 'Change From Baseline in 24-hour Urine Aldosterone', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour urine aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)'}, {'measure': 'Change From Baseline in 24-hour Serum Aldosterone', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour serum aldosterone levels with CIN 107 compared to placebo after 8 weeks of treatment (Part 1)'}, {'measure': 'Percentage of Patients Achieving a Mean Seated SBP <130 mmHg', 'timeFrame': '8 weeks', 'description': 'The percentage of patients achieving a mean seated SBP \\<130 mmHg ("responders") with CIN-107 compared to placebo after 8 weeks of treatment (Part 1; Weeks 1 to 8)'}, {'measure': 'Change From Baseline in 24-hour Urine Renin', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour urine renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)'}, {'measure': 'Change From Baseline in 24-hour Serum Renin', 'timeFrame': '8 weeks', 'description': 'The change from baseline in 24-hour serum renin levels with CIN-107 compared to placebo after 8 weeks of treatment (Part 1)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uncontrolled Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.\n\nParticipants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;\n* Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;\n* Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period\n* If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and\n* Agrees to comply with the contraception and reproduction restrictions of the study;\n\nExclusion Criteria:\n\n* Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;\n* Has a body mass index (BMI) \\>50 kg/m2;\n* Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);\n* Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;\n* Has documented estimated eGFR \\<30 mL/min/1.73m2;\n* Has known and documented New York Heart Association stage III or IV chronic heart failure;\n* Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;\n* Major cardiac surgery within 6 months before Screening;\n* Has chronic permanent atrial fibrillation;\n* Has uncontrolled diabetes with glycated hemoglobin \\>10% at Screening;\n* Has planned dialysis or kidney transplantation planned during the course of the study;\n* Prior solid organ transplant and/or cell transplants;\n* Sodium \\<130 mEq/L;\n* Potassium \\<3.5 mEq/L;\n* Potassium \\>5 mEq/L;\n* White blood cell count \\>15 × E9/L or absolute neutrophil count \\<1 × E9/L at Screening;\n* Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;\n* Has typical consumption of ≥14 alcoholic drinks weekly;'}, 'identificationModule': {'nctId': 'NCT05137002', 'acronym': 'HALO', 'briefTitle': 'A Study of CIN-107 in Patients With Uncontrolled Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'CinCor Pharma, Inc.'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension', 'orgStudyIdInfo': {'id': 'CIN-107-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIN-107 0.5 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks', 'interventionNames': ['Drug: CIN-107']}, {'type': 'EXPERIMENTAL', 'label': 'CIN-107 1 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks', 'interventionNames': ['Drug: CIN-107']}, {'type': 'EXPERIMENTAL', 'label': 'CIN-107 2 mg', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control', 'interventionNames': ['Drug: CIN-107']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CIN-107', 'type': 'DRUG', 'otherNames': ['Baxdrostat'], 'description': 'CIN-107 tablets by mouth once daily', 'armGroupLabels': ['CIN-107 0.5 mg', 'CIN-107 1 mg', 'CIN-107 2 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets by mouth once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36571', 'city': 'Saraland', 'state': 'Alabama', 'country': 'United States', 'facility': 'CinCor Site 27', 'geoPoint': {'lat': 30.82074, 'lon': -88.07056}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'CinCor Site 35', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 69', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 6', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 20', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90262', 'city': 'Lynwood', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 70', 'geoPoint': {'lat': 33.93029, 'lon': -118.21146}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 36', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92049', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 29', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 46', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '91773', 'city': 'San Dimas', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 47', 'geoPoint': {'lat': 34.10668, 'lon': -117.80673}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 49', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 52', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'CinCor Site 57', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CinCor Site 31', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 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