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

Last updated: April 17, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Baxdrostat

Clinical Study ID

NCT07007793
D6974C00001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants must be ≥ 18 years of age

  • Participants with a documented diagnosis of PA that fulfils the criteria defined inthe 2016 or 2025 Endocrine Society Guidelines.

  • Participants willing and able to cease dosing of MRA or potassium sparing diureticsper study requirement for participants taking an MRA or potassium sparing diureticat Screening.

  • eGFR ≥ 45 mL/min/1.73m2 at Screening

  • Serum potassium level ≥ 3.0 and < 5.0 mmol/L at Screening determined as per thecentral laboratory.

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

  • 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

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 plannedadrenalectomy, renal nerve denervation, or adrenal ablative procedure during thecourse of the study.

  • Has the following known secondary causes of HTN: renal artery stenosis, uncontrolledor 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 toRandomisation.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 07, 2025
Estimated Completion Date:
February 18, 2028

Connect with a study center

  • Research Site

    Brisbane, 4102
    Australia

    Active - Recruiting

  • Research Site

    Brisbane 2174003, 4102
    Australia

    Site Not Available

  • Research Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Research Site

    Clayton 2171400, 3168
    Australia

    Site Not Available

  • Research Site

    Perth, 6000
    Australia

    Active - Recruiting

  • Research Site

    Perth 2063523, 6000
    Australia

    Site Not Available

  • Research Site

    Calgary, Alberta T2T 5C7
    Canada

    Active - Recruiting

  • Research Site

    Calgary 5913490, Alberta 5883102 T2T 5C7
    Canada

    Site Not Available

  • Research Site

    Ottawa, Ontario K1H 7W9
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M4G 3E8
    Canada

    Active - Recruiting

  • Research Site

    Ottawa 6094817, Ontario 6093943 K1H 7W9
    Canada

    Site Not Available

  • Research Site

    Toronto 6167865, Ontario 6093943 M4G 3E8
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4J 1C5
    Canada

    Active - Recruiting

  • Research Site

    Montreal 6077243, Quebec 6115047 H4J 1C5
    Canada

    Site Not Available

  • Research Site

    Beijing, 100191
    China

    Active - Recruiting

  • Research Site

    Beijing 1816670, 100044
    China

    Site Not Available

  • Research Site

    Changsha, 430033
    China

    Active - Recruiting

  • Research Site

    Changsha 1815577, 430033
    China

    Site Not Available

  • Research Site

    Chengdu, 610500
    China

    Site Not Available

  • Research Site

    Chengdu 1815286, 610041
    China

    Site Not Available

  • Research Site

    Chongqing, 400042
    China

    Active - Recruiting

  • Research Site

    Chongqing 1814906, 400042
    China

    Site Not Available

  • Research Site

    Nanjing, 2100008
    China

    Active - Recruiting

  • Research Site

    Nanjing 1799962, 2100008
    China

    Site Not Available

  • Research Site

    Shanghai, 200025
    China

    Active - Recruiting

  • Research Site

    Shanghai 1796236, 200025
    China

    Site Not Available

  • Research Site

    Tianjin, 300050
    China

    Active - Recruiting

  • Research Site

    Tianjin 1792947, 300050
    China

    Site Not Available

  • Research Site

    Wuhan, 430060
    China

    Active - Recruiting

  • Research Site

    Wuhan 1791247, 430030
    China

    Site Not Available

  • Research Site

    Xianyang, 750004
    China

    Active - Recruiting

  • Research Site

    Xianyang 1790353, 750004
    China

    Site Not Available

  • Research Site

    Amiens, 80054
    France

    Active - Recruiting

  • Research Site

    Amiens 3037854, 80054
    France

    Site Not Available

  • Research Site

    Bois-Guillaume, 76230
    France

    Active - Recruiting

  • Research Site

    Bois-Guillaume 3032025, 76230
    France

    Site Not Available

  • Research Site

    Bordeaux, 33076
    France

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  • Research Site

    Bordeaux 3031582, 33076
    France

    Site Not Available

  • Research Site

    Lille, 59037
    France

    Active - Recruiting

  • Research Site

    Lille 2998324, 59037
    France

    Site Not Available

  • Research Site

    Marseille, 13005
    France

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  • Research Site

    Marseille 2995469, 13005
    France

    Site Not Available

  • Research Site

    Paris, 75908
    France

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  • Research Site

    Paris 2988507, 75018
    France

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  • Research Site

    Berlin, 12203
    Germany

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  • Research Site

    Berlin 2950159, 12203
    Germany

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  • Research Site

    Düsseldorf, 40225
    Germany

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  • Research Site

    Düsseldorf 2934246, 40225
    Germany

    Site Not Available

  • Research Site

    Kaiserslautern, 67655
    Germany

    Active - Recruiting

  • Research Site

    Kaiserslautern 2894003, 67655
    Germany

    Site Not Available

  • Research Site

    München, 80336
    Germany

    Active - Recruiting

  • Research Site

    München 2867711, 80336
    Germany

    Site Not Available

  • Research Site

    Reinfeld (Holstein), 23858
    Germany

    Active - Recruiting

  • Research Site

    Reinfeld (Holstein) 2848811, 23858
    Germany

    Site Not Available

  • Research Site

    Würzburg, 97080
    Germany

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  • Research Site

    Würzburg 2805615, 97080
    Germany

    Site Not Available

  • Research Site

    Belagavi, 590010
    India

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  • Research Site

    Belagavi 1276533, 590010
    India

    Site Not Available

  • Research Site

    Delhi, 110029
    India

    Active - Recruiting

  • Research Site

    Delhi 1273294, 110029
    India

    Site Not Available

  • Research Site

    Hyderabad, 500012
    India

    Active - Recruiting

  • Research Site

    Hyderabad 1269843, 500012
    India

    Site Not Available

  • Research Site

    Kolkata, 700020
    India

    Active - Recruiting

  • Research Site

    Kolkata 1275004, 700020
    India

    Site Not Available

  • Research Site

    Mumbai, 400012
    India

    Active - Recruiting

  • Research Site

    Mumbai 1275339, 400008
    India

    Site Not Available

  • Research Site

    Bologna, 40138
    Italy

    Active - Recruiting

  • Research Site

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • Research Site

    Brescia, 25123
    Italy

    Active - Recruiting

  • Research Site

    Brescia 3181554, 25123
    Italy

    Site Not Available

  • Research Site

    Firenze, 50134
    Italy

    Site Not Available

  • Research Site

    Florence, 50134
    Italy

    Active - Recruiting

  • Research Site

    Florence 3176959, 50134
    Italy

    Site Not Available

  • Research Site

    Milan, 20149
    Italy

    Active - Recruiting

  • Research Site

    Milan 6951411, 20162
    Italy

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  • Research Site

    Milano, 20162
    Italy

    Site Not Available

  • Research Site

    Torino, 10126
    Italy

    Active - Recruiting

  • Research Site

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Research Site

    Kawasaki-shi, 216-8511
    Japan

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  • Research Site

    Kodaira-shi, 187-8510
    Japan

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  • Research Site

    Minatoku, 108-8329
    Japan

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  • Research Site

    Minatoku 11191118, 108-8329
    Japan

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  • Research Site

    Shinjuku-ku, 162-8666
    Japan

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  • Research Site

    Yokohama, 230-8765
    Japan

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  • Research Site

    Yokohama 1848354, 230-8765
    Japan

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  • Research Site

    Yufu-shi, 879-5593
    Japan

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  • Research Site

    Ōta-ku, 143-8541
    Japan

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  • Research Site

    Ōta-ku 8469289, 143-8541
    Japan

    Site Not Available

  • Research Site

    Barcelona, 08036
    Spain

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  • Research Site

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Research Site

    Madrid, 28046
    Spain

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  • Research Site

    Madrid 3117735, 28040
    Spain

    Site Not Available

  • Research Site

    Sevilla, 41013
    Spain

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  • Research Site

    Seville, 41013
    Spain

    Active - Recruiting

  • Research Site

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Research Site

    Kaohsiung City, 80756
    Taiwan

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  • Research Site

    Kaohsiung City 1673820, 80756
    Taiwan

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  • Research Site

    Taichung, 40705
    Taiwan

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  • Research Site

    Taichung 1668399, 40705
    Taiwan

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  • Research Site

    Taipei, 10002
    Taiwan

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  • Research Site

    Taipei 1668341, 10002
    Taiwan

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  • Research Site

    Taoyuan District, 333
    Taiwan

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  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

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  • Research Site

    Yunlin, 640
    Taiwan

    Active - Recruiting

  • Research Site

    Zhubei, 302
    Taiwan

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  • Research Site

    Zhubei 1677112, 302
    Taiwan

    Site Not Available

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

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  • Research Site

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Site Not Available

  • Research Site

    Cardiff, CF14 4XW
    United Kingdom

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  • Research Site

    Cardiff 2653822, CF14 4XW
    United Kingdom

    Site Not Available

  • Research Site

    Dundee, DD1 9SY
    United Kingdom

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  • Research Site

    Dundee 2650752, DD1 9SY
    United Kingdom

    Site Not Available

  • Research Site

    London, SE1 9RT
    United Kingdom

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  • Research Site

    London 2643743, EC1A 7BE
    United Kingdom

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  • Research Site

    Los Angeles, California 90048
    United States

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  • Research Site

    San Francisco, California 94110
    United States

    Site Not Available

  • Research Site

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • Research Site

    San Francisco 5391959, California 5332921 94110
    United States

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  • Research Site

    Farmington, Connecticut 06030
    United States

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  • Research Site

    Farmington 4834272, Connecticut 4831725 06030
    United States

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  • Research Site

    Chicago, Illinois 60611
    United States

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  • Research Site

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Research Site

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Research Site

    Springfield 4250542, Illinois 4896861 62702
    United States

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  • Research Site

    Baltimore, Maryland 21287
    United States

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  • Research Site

    Baltimore 4347778, Maryland 4361885 21287
    United States

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  • Research Site

    Boston, Massachusetts 02115
    United States

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  • Research Site

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

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  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Research Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Research Site

    Olive Branch, Mississippi 38654
    United States

    Active - Recruiting

  • Research Site

    Olive Branch 4439869, Mississippi 4436296 38654
    United States

    Site Not Available

  • Research Site

    Kansas City, Missouri 64151
    United States

    Site Not Available

  • Research Site

    Kansas City 4393217, Missouri 4398678 64151
    United States

    Site Not Available

  • Research Site

    New York, New York 10065
    United States

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  • Research Site

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Research Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Research Site

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • Research Site

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Research Site

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Site

    Bethlehem 5180225, Pennsylvania 6254927 18017
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Research Site

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Research Site

    Columbia 4575352, South Carolina 4597040 29203
    United States

    Site Not Available

  • Research Site

    Brownsville, Texas 78526
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Research Site

    Brownsville 4676740, Texas 4736286 78526
    United States

    Site Not Available

  • Research Site

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

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