Clinical Research Directory
Browse clinical research sites, groups, and studies.
Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
Sponsor: AstraZeneca
Summary
Parent study: 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 250 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. Sub-study: The purpose of this study is to describe PA disease characteristics after completing baxdrostat treatment in participants with PA. Investigational medicinal product (IMP) will not be administered during the substudy. Study details include: * The study duration will be up to 70 ± 9 weeks. * The visits will be at Week 13 (Visit 2), Week 26 (Visit 3), Week 52 (Visit 4), and up to Week 70 (Visit 5).
Official title: Parent Study: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism Sub-study: A Substudy to Describe PA Disease Characteristics After Completion of the BaxPA Main Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2025-08-07
Completion Date
2028-08-14
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD).
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Locations (76)
Research Site
San Francisco, California, United States
Research Site
Farmington, Connecticut, United States
Research Site
Springfield, Illinois, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Rochester, Minnesota, United States
Research Site
Olive Branch, Mississippi, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Bethlehem, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Columbia, South Carolina, United States
Research Site
Dallas, Texas, United States
Research Site
Brisbane, Australia
Research Site
Clayton, Australia
Research Site
Perth, Australia
Research Site
Calgary, Alberta, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Tianjin, China
Research Site
Wuhan, China
Research Site
Wuhan, China
Research Site
Amiens, France
Research Site
Bois-Guillaume, France
Research Site
Bordeaux, France
Research Site
Lille, France
Research Site
Paris, France
Research Site
Paris, France
Research Site
Berlin, Germany
Research Site
Düsseldorf, Germany
Research Site
Kaiserslautern, Germany
Research Site
München, Germany
Research Site
Würzburg, Germany
Research Site
Belagavi, India
Research Site
Delhi, India
Research Site
Hyderabad, India
Research Site
Kolkata, India
Research Site
Mumbai, India
Research Site
Bologna, Italy
Research Site
Brescia, Italy
Research Site
Florence, Italy
Research Site
Milan, Italy
Research Site
Milan, Italy
Research Site
Torino, Italy
Research Site
Kawasaki-shi, Japan
Research Site
Kodaira-shi, Japan
Research Site
Minatoku, Japan
Research Site
Ōta-ku, Japan
Research Site
Shinjuku-ku, Japan
Research Site
Yokohama, Japan
Research Site
Yufu-shi, Japan
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Seville, Spain
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan, Taiwan
Research Site
Zhubei, Taiwan
Research Site
Cambridge, United Kingdom
Research Site
Cardiff, United Kingdom
Research Site
Dundee, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom