Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-02-04 @ 4:15 PM
Study NCT ID:
NCT06344104
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'placebo control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to week 54', 'description': 'To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI)'}], 'primaryOutcomes': [{'measure': 'Change from baseline in seated SBP at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in seated SBP at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12'}, {'measure': 'Change from RWD baseline (Week 24) in seated SBP at Week 32', 'timeFrame': 'At Week 32', 'description': 'To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at 8 weeks after randomised withdrawal'}, {'measure': 'Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12'}, {'measure': 'Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12'}, {'measure': 'Change from baseline in seated DBP at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 2 mg baxdrostat versus placebo on seated DBP at Week 12'}, {'measure': 'Achieving seated SBP < 140 mmHg at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 2 mg baxdrostat versus placebo on achieving seated SBP \\< 140 mmHg at Week 12'}, {'measure': 'Change from baseline in seated DBP at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 1 mg baxdrostat versus placebo on seated DBP at Week 12'}, {'measure': 'Achieving seated SBP < 140 mmHg at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 1 mg baxdrostat versus placebo on achieving seated SBP \\< 140 mmHg at Week 12'}, {'measure': 'Change from baseline in seated SBP at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup'}, {'measure': 'Change from baseline in seated SBP at Week 12', 'timeFrame': 'At Week 12', 'description': 'To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Uncontrolled hypertension', 'Resistant hypertension', 'Blood pressure', 'Baxdrostat', 'CIN-107', 'Aldosterone', 'Aldosterone synthase'], 'conditions': ['Uncontrolled Hypertension', 'Resistant Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.', 'detailedDescription': 'This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants must be ≥ 18 years old.\n* Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.\n* Fulfil at least 1 of the following 2 criteria:\n\n 1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.\n 2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.\n* Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.\n* Serum potassium (K+) level ≥ 3.5 and \\< 5.0 mmol/L at Screening.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.\n\nExclusion Criteria:\n\n* Mean seated SBP on AOBPM ≥ 170 mmHg.\n* Mean seated DBP on AOBPM ≥ 105 mmHg.\n* Serum sodium level (Na+) \\< 135 mmol/L at Screening.\n* Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.\n* NYHA functional heart failure class IV at Screening."}, 'identificationModule': {'nctId': 'NCT06344104', 'acronym': 'BaxAsia', 'briefTitle': 'A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension', 'orgStudyIdInfo': {'id': 'D6970C00008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 mg baxdrostat', 'description': '2 mg baxdrostat administered orally, once daily (QD)', 'interventionNames': ['Drug: Baxdrostat']}, {'type': 'EXPERIMENTAL', 'label': '1 mg baxdrostat', 'description': '1 mg baxdrostat administered orally, once daily (QD).', 'interventionNames': ['Drug: Baxdrostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo administered orally, once daily (QD)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Baxdrostat', 'type': 'DRUG', 'otherNames': ['CIN-107'], 'description': 'Baxdrostat tablet administered orally, once daily (QD). Unit dose strength:\n\n* 1 mg per tablet for 1mg baxdrostat Arm\n* 2 mg per tablet for 2mg baxdrostat Arm', 'armGroupLabels': ['1 mg baxdrostat', '2 mg baxdrostat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet administered orally, once daily (QD).', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bahía Blanca', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -38.7176, 'lon': -62.26545}}, {'zip': 'C1426', 'city': 'CABA', 'country': 'Argentina', 'facility': 'Research Site'}, {'zip': 'C1419AHL', 'city': 'Ciudad de Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site'}, {'zip': 'T4000ICL', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'B2900DPA', 'city': 'San Nicolás de los Arroyos', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -33.33425, 'lon': 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