Status:
RECRUITING
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Lead Sponsor:
AstraZeneca
Conditions:
Primary Hyperaldosteronism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction o...
Eligibility Criteria
Inclusion Criteria:
-
Male or female participants must be ≥ 18 years of age
-
Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
-
Participants willing and able to cease dosing of MRA or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.
-
eGFR ≥ 45 mL/min/1.73m2 at Screening
-
Serum potassium level ≥ 3.0 and < 5.0 mmol/L at Screening determined as per the central laboratory.
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Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
-
Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of
≤ 105 mmHg.
-
Serum potassium (local lab) > 3.0 mmol/L at randomization.
Exclusion Criteria:
- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 170 mmHg or mean seated DBP >105 mmHg (on AOBPM).
If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 160 mmHg or mean seated DBP ≥ 100 mmHg.
- Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
- Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
- Serum sodium level < 135 mmol/L at Screening, determined as per central laboratory.
- New York Heart Association functional HF class IV at Screening.
- Persistent atrial fibrillation.
- Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.
Key Trial Info
Start Date :
August 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 18 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07007793
Start Date
August 7 2025
End Date
February 18 2028
Last Update
February 19 2026
Active Locations (89)
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1
Research Site
Los Angeles, California, United States, 90048
2
Research Site
San Francisco, California, United States, 94110
3
Research Site
Farmington, Connecticut, United States, 06030
4
Research Site
Chicago, Illinois, United States, 60611