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NCT07007793PHASE3Recruiting

A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

AstraZeneca

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

Inclusion Criteria: * 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 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 not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 170 mmHg or mean seated DBP \>105 mmHg (on AOBPM). 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.

Interventions

DRUG

Baxdrostat

DRUG

Placebo

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Conditions

Primary Hyperaldosteronism

Locations

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Los Angeles, California 90048

United States

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San Francisco, California 94110

United States

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Farmington, Connecticut 06030

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Chicago, Illinois 60611

United States

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Springfield, Illinois 62702

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Baltimore, Maryland 21287

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Boston, Massachusetts 02111

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Boston, Massachusetts 02115

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Ann Arbor, Michigan 48109

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Rochester, Minnesota 55902

United States

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Olive Branch, Mississippi 38654

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Kansas City, Missouri 64151

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New York, New York 10065

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Cleveland, Ohio 44195

United States

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Columbus, Ohio 43210

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Portland, Oregon 97239

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Bethlehem, Pennsylvania 18017

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Philadelphia, Pennsylvania 19104

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Columbia, South Carolina 29203

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Brownsville, Texas 78526

United States

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Dallas, Texas 75390

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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