A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism
AstraZeneca
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 le…
Interventions
- DrugBaxdrostat
Baxdrostat tablet administered orally, once daily (QD).
- DrugPlacebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Locations (89)
- Research SiteLos Angeles, California
- Research SiteSan Francisco, California
- Research SiteFarmington, Connecticut
- Research SiteChicago, Illinois
- Research SiteSpringfield, Illinois
- Research SiteBaltimore, Maryland