A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
NCT ID: NCT07007793
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-08-07
2028-02-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Baxdrostat
Baxdrostat administered orally, once daily (QD).
Baxdrostat
Baxdrostat tablet administered orally, once daily (QD).
Placebo
Matching placebo administered orally, once daily (QD).
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Interventions
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Baxdrostat
Baxdrostat tablet administered orally, once daily (QD).
Placebo
Placebo tablet matching baxdrostat, administered orally, once daily (QD).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 least 4 weeks prior to randomisation
* Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of
≤ 105 mmHg.
* Serum potassium (local lab) \> 3.0 mmol/L at randomization.
Exclusion Criteria
If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 160 mmHg or mean seated DBP ≥ 100 mmHg.
* Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
* Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
* Serum sodium level \< 135 mmol/L at Screening, determined as per central laboratory.
* New York Heart Association functional HF class IV at Screening.
* Persistent atrial fibrillation.
* Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
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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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
Countries
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Central Contacts
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Other Identifiers
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D6974C00001
Identifier Type: -
Identifier Source: org_study_id
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