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.

  • 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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Page 1 of 23 (89 locations)

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