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A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Sponsor: 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.
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-08-07
Completion Date
2028-02-18
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD).
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Locations (89)
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Los Angeles, California, United States
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San Francisco, California, United States
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Farmington, Connecticut, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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Olive Branch, Mississippi, United States
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Kansas City, Missouri, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Brownsville, Texas, United States
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Dallas, Texas, United States
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Brisbane, Australia
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Clayton, Australia
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Perth, Australia
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Calgary, Alberta, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Nanjing, China
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Shanghai, China
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Tianjin, China
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Wuhan, China
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Wuhan, China
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Xianyang, China
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Amiens, France
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Bois-Guillaume, France
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Bordeaux, France
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Lille, France
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Marseille, France
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Paris, France
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Paris, France
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Berlin, Germany
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Düsseldorf, Germany
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Kaiserslautern, Germany
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München, Germany
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Reinfeld (Holstein), Germany
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Würzburg, Germany
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Belagavi, India
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Delhi, India
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Hyderabad, India
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Kolkata, India
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Mumbai, India
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Mumbai, India
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Bologna, Italy
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Brescia, Italy
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Florence, Italy
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Milan, Italy
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Milan, Italy
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Torino, Italy
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Kawasaki-shi, Japan
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Kodaira-shi, Japan
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Minatoku, Japan
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Ōta-ku, Japan
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Shinjuku-ku, Japan
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Yokohama, Japan
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Yufu-shi, Japan
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Seville, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Yunlin, Taiwan
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Zhubei, Taiwan
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Dundee, United Kingdom
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London, United Kingdom
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London, United Kingdom