Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Uncontrolled Hypertension
Resistant Hypertension
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
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, administe...
Eligibility Criteria
Inclusion
- Male or female participants must be ≥ 18 years old
- Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and \< 170 mmHg at Screening
- Fulfil at least 1 of the following 2 criteria:
- uHTN subpopulation: have a stable regimen 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
- rHTN subpopulation: 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
- Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening
- Serum potassium (K+) level ≥ 3.5 and \< 5.0 mmol/L at Screening
- Randomisation Criterion:
- Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit
Exclusion
- Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
- Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
- Serum sodium level \< 135 mmol/L at Screening
- 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 heart failure class IV at Screening
- Persistent atrial fibrillation
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2025
Estimated Enrollment :
796 Patients enrolled
Trial Details
Trial ID
NCT06034743
Start Date
November 22 2023
End Date
October 10 2025
Last Update
November 7 2025
Active Locations (263)
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1
Research Site
Saraland, Alabama, United States, 36571
2
Research Site
Scottsdale, Arizona, United States, 85054
3
Research Site
Sun City West, Arizona, United States, 85375
4
Research Site
Surprise, Arizona, United States, 85374