A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism

Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 unsuppression of Plasma Renin Activity (PRA) 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 to based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 orpotassium sparing diuretics per study requirement for participantstaking 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 Screeningdetermined as per the central laboratory.

• Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation

• Mean seated SBP on AOBPM of ≥ 135 mmHg.

Locations
United States
California
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Los Angeles
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San Francisco
Connecticut
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Farmington
Illinois
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Chicago
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Springfield
Massachusetts
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Boston
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Boston
Maryland
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Baltimore
Michigan
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Ann Arbor
Minnesota
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Rochester
Missouri
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Kansas City
Mississippi
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Olive Branch
New York
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New York
Ohio
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Cleveland
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Columbus
Pennsylvania
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Bethlehem
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Philadelphia
South Carolina
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Columbia
Texas
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Brownsville
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Dallas
Other Locations
Australia
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Brisbane
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Clayton
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Perth
Canada
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Calgary
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Montreal
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Ottawa
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Toronto
China
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Beijing
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Beijing
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Beijing
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Changsha
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WITHDRAWN
Chengdu
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Chengdu
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Chongqing
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Nanjing
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Shanghai
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Tianjin
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Wuhan
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Wuhan
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Xianyang
France
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Amiens
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Bois-guillaume
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Bordeaux
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Lille
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Marseille
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Paris
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Paris
Germany
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Berlin
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Düsseldorf
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Kaiserslautern
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München
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Reinfeld (holstein)
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Würzburg
India
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Belagavi
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Delhi
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Hyderabad
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Kolkata
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Mumbai
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Mumbai
Italy
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Bologna
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Brescia
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Florence
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Milan
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Milan
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Torino
Japan
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Kawasaki-shi
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Kodaira-shi
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Minatoku
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Ōta-ku
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Shinjuku-ku
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Yokohama
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Yufu-shi
Spain
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Barcelona
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Madrid
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Madrid
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Madrid
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Seville
Taiwan
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Kaohsiung City
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Taichung
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Taipei
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Taoyuan District
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NOT_YET_RECRUITING
Yunlin
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Zhubei
United Kingdom
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Cambridge
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Cardiff
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Dundee
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London
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London
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2028-02-18
Participants
Target number of participants: 180
Treatments
Experimental: Baxdrostat
Baxdrostat administered orally, once daily (QD).
Placebo_comparator: Placebo
Matching placebo administered orally, once daily (QD).
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov