A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Start Date
8/7/2025
Completion Date
8/14/2028
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 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Baxdrostat
Placebo
Conditions
Locations
Research Site
Los Angeles, California 90048
United States
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San Francisco, California 94110
United States
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Farmington, Connecticut 06030
United States
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Chicago, Illinois 60611
United States
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Springfield, Illinois 62702
United States
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Baltimore, Maryland 21287
United States
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Boston, Massachusetts 02111
United States
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Boston, Massachusetts 02115
United States
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Ann Arbor, Michigan 48109
United States
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Rochester, Minnesota 55902
United States
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Olive Branch, Mississippi 38654
United States
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Kansas City, Missouri 64151
United States
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New York, New York 10065
United States
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Cleveland, Ohio 44195
United States
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Columbus, Ohio 43210
United States
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Portland, Oregon 97239
United States
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Bethlehem, Pennsylvania 18017
United States
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Philadelphia, Pennsylvania 19104
United States
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Columbia, South Carolina 29203
United States
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Brownsville, Texas 78526
United States
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Dallas, Texas 75390
United States
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Brisbane, 4102
Australia
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Clayton, 3168
Australia
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Perth, 6000
Australia
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Calgary, Alberta T2T 5C7
Canada
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Ottawa, Ontario K1H 7W9
Canada
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Toronto, Ontario M4G 3E8
Canada
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Montreal, Quebec H4J 1C5
Canada
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Beijing, 100034
China
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Beijing, 100044
China
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Beijing, 100191
China
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Changsha, 430033
China
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Chengdu, 610041
China
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Chengdu, 610500
China
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Chongqing, 400042
China
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Nanjing, 2100008
China
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Shanghai, 200025
China
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Tianjin, 300050
China
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Wuhan, 430030
China
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Wuhan, 430060
China
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Xianyang, 750004
China
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Amiens, 80054
France
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Bois-Guillaume, 76230
France
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Bordeaux, 33076
France
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Lille, 59037
France
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Marseille, 13005
France
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Paris, 75018
France
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Paris, 75908
France
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Berlin, 12203
Germany
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Düsseldorf, 40225
Germany
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Kaiserslautern, 67655
Germany
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München, 80336
Germany
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Reinfeld (Holstein), 23858
Germany
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Würzburg, 97080
Germany
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Belagavi, 590010
India
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Delhi, 110029
India
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Hyderabad, 500012
India
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Kolkata, 700020
India
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Mumbai, 400008
India
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Mumbai, 400012
India
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Bologna, 40138
Italy
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Brescia, 25123
Italy
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Florence, 50134
Italy
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Milan, 20149
Italy
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Milan, 20162
Italy
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Torino, 10126
Italy
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Kawasaki-shi, 216-8511
Japan
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Kodaira-shi, 187-8510
Japan
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Minatoku, 108-8329
Japan
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Ōta-ku, 143-8541
Japan
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Shinjuku-ku, 162-8666
Japan
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Yokohama, 230-8765
Japan
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Yufu-shi, 879-5593
Japan
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Barcelona, 08036
Spain
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Madrid, 28034
Spain
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Madrid, 28040
Spain
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Madrid, 28046
Spain
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Seville, 41013
Spain
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Kaohsiung City, 80756
Taiwan
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Taichung, 40705
Taiwan
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Taipei, 10002
Taiwan
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Taoyuan, 333
Taiwan
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Yunlin, 640
Taiwan
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Zhubei, 302
Taiwan
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Cambridge, CB2 0QQ
United Kingdom
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Cardiff, CF14 4XW
United Kingdom
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Dundee, DD1 9SY
United Kingdom
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London, EC1A 7BE
United Kingdom
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London, SE1 9RT
United Kingdom