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

NCT07007793 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-20

No results posted yet for this study

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

DRUG

Baxdrostat

Baxdrostat tablet administered orally, once daily (QD).

DRUG

Placebo

Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-07
Primary Completion
2028-02-18
Completion
2028-02-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Germany
  • India
  • Italy
  • Japan
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07007793 on ClinicalTrials.gov