Status:
COMPLETED
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
Lead Sponsor:
AstraZeneca
Conditions:
Resistant Hypertension
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD...
Detailed Description
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered...
Eligibility Criteria
Inclusion
- Participant must be ≥ 18 years old, at the time of signing the informed consent.
- Mean seated SBP on AOBPM of ≥ 140 mmHg and \< 170 mmHg at Screening.
- Have a stable regimen 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, for at least 4 weeks prior to screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
- Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
- Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening, determined as per central laboratory
- Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.
Exclusion
- Mean seated SBP on AOBPM ≥ 170 mmHg.
- Mean seated DBP on AOBPM ≥ 110 mmHg.
- Serum sodium level \< 135 mmol/L at Screening, as per central laboratory.
- Participant 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.
- New York Heart Association functional HF class IV.
- Persistent atrial fibrillation.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2025
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT06168409
Start Date
March 1 2024
End Date
August 17 2025
Last Update
October 3 2025
Active Locations (102)
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1
Research Site
Surprise, Arizona, United States, 85374
2
Research Site
Hollywood, Florida, United States, 33024
3
Research Site
Lake Worth, Florida, United States, 33467
4
Research Site
Port Charlotte, Florida, United States, 33952