NCT07007793

A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries.

Conditions

• Primary Hyperaldosteronism

Interventions

Type	Name	Description
DRUG	Baxdrostat	Baxdrostat tablet administered orally, once daily (QD).
DRUG	Placebo	Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Timeline

• Start date: 2025-08-07
• Primary completion: 2028-02-18
• Completion: 2028-02-18
• First posted: 2025-06-06
• Last updated: 2026-02-19

Locations

89 sites across 12 countries: United States, Australia, Canada, China, France, Germany, India, Italy, Japan, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study