Baxdrostat
Sponsors
Astrazeneca AB, AstraZeneca AB, AstraZeneca
Conditions
Chronic kidney disease (CKD) and hypertension.Healthy ParticipantsHypertensionPrevention of Heart failurePrimary Aldosteronism defined by excess aldosterone secretionPrimary HyperaldosteronismResistant HypertensionResistant hypertension (rHTN) defined as blood pressure that remains higher than goal levels despite the use of at least 3 anti hypertensive drugs of different classes at maximum tolerated dose
Phase 1
Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
CompletedNCT05961384
Start: 2021-11-18End: 2022-01-15Updated: 2023-08-15
Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment
CompletedNCT05961397
Start: 2021-08-10End: 2022-04-15Updated: 2023-08-14
Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population
CompletedNCT05966324
Start: 2022-07-05End: 2022-09-20Updated: 2023-08-14
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants
CompletedNCT06194032
Start: 2024-02-29End: 2024-05-13Updated: 2025-04-25
A Study to Investigate the Pharmacokinetics of Baxdrostat When Given Alone and in Combination With Itraconazole in Healthy Participants
CompletedNCT06357520
Start: 2024-04-16End: 2024-06-17Updated: 2024-07-03
A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential
CompletedNCT06657105
Start: 2024-11-01End: 2025-02-03Updated: 2025-02-07
Phase 2
A Study to Evaluate Cortisol Reserve in Response to Adrenocorticotropic Hormone (ACTH) Stimulation Test Following Baxdrostat Treatment Compared to Placebo in Participants With Uncontrolled Hypertension
CompletedNCT06336356
Start: 2024-06-10End: 2024-12-04Updated: 2025-12-17
A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Baxdrostat on Albuminuria in Participants with Chronic Kidney Disease and High Blood Pressure
Not yet recruitingCTIS2025-522407-23-00
Target: 28Updated: 2026-02-16
Phase 3
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
CompletedNCT06034743
Start: 2023-11-22End: 2025-10-10Updated: 2025-11-07
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
CompletedNCT06168409
Start: 2024-03-01End: 2025-08-17Updated: 2026-02-06
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants with Uncontrolled Hypertension on Two or More Medications including Participants with Resistant Hypertension
CompletedCTIS2023-505499-32-00
Start: 2024-03-08End: 2025-10-07Target: 205Updated: 2025-08-25
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
Active, not recruitingNCT06344104
Start: 2024-04-08End: 2026-04-03Updated: 2026-03-27
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants with Resistant Hypertension.
CompletedCTIS2023-507640-36-00
Start: 2024-04-29End: 2025-08-08Target: 79Updated: 2025-07-04
A Phase III, Randomised, Double-Blind, Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure
Active, not recruitingCTIS2023-506457-38-00
Start: 2024-06-05Target: 675Updated: 2025-11-06
A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants with Chronic Kidney Disease and High Blood Pressure.
RecruitingCTIS2023-506460-14-00
Start: 2025-05-07Target: 1134Updated: 2025-11-05
A Phase III, Randomised, Double-Blind, Placebo-controlled, Event driven Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death in Participants with Increased Risk of Developing Heart Failure
RecruitingCTIS2024-514506-32-00
Start: 2025-05-06Target: 3868Updated: 2025-11-03
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
RecruitingNCT07007793
Start: 2025-08-07End: 2028-02-18Target: 180Updated: 2026-02-19
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants with Primary Aldosteronism
RecruitingCTIS2025-520740-16-00
Start: 2025-09-19Target: 49Updated: 2025-11-14