A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Last updated: March 17, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Circulation Disorders

High Blood Pressure (Hypertension - Pediatric)

Treatment

Placebo

Baxdrostat

Clinical Study ID

NCT06168409
D6970C00009
2023-507640-36-00
  • Ages 18-130
  • All Genders

Study Summary

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥ 18 years old, at the time of signing the informed consent.

  • Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.

  • Have a stable regimen of ≥ 3 antihypertensive medications, from differenttherapeutic classes (at least one should be a diuretic), at maximum tolerated dosein the judgement of the Investigator, for at least 4 weeks prior to Screening (participants who do not meet this criterion may be rescreened at the Investigator'sdiscretion). Beta blockers used to treat other conditions (ie, migraine, HF,coronary artery disease) should not be counted as an antihypertensive medication forthe purpose of qualifying for this study.

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

  • Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as percentral laboratory

  • Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

Exclusion

Exclusion Criteria:

  • Mean seated SBP on AOBPM ≥ 170 mmHg at Screening.

  • Mean seated DBP on AOBPM ≥ 110 mmHg at Screening.

  • Serum sodium level < 135 mmol/L at Screening, as per central laboratory.

  • Participant has the following known secondary causes of hypertension: renal arterystenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreatedhypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.

  • New York Heart Association functional HF class IV at Screening.

  • Persistent atrial fibrillation.

Study Design

Total Participants: 212
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 01, 2024
Estimated Completion Date:
September 05, 2025

Study Description

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.

Connect with a study center

  • Research Site

    Caba, C1119ACN
    Argentina

    Site Not Available

  • Research Site

    Capital Federal, C1060ABN
    Argentina

    Site Not Available

  • Research Site

    Cordoba, X5003DCP
    Argentina

    Site Not Available

  • Research Site

    Lanus Este, B1824KAJ
    Argentina

    Site Not Available

  • Research Site

    Rosario, S2000PBJ
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucuman, 4000
    Argentina

    Site Not Available

  • Research Site

    San Vicente, 5006
    Argentina

    Site Not Available

  • Research Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Research Site

    Perth, 6000
    Australia

    Active - Recruiting

  • Research Site

    Gent, 9000
    Belgium

    Completed

  • Research Site

    Mons, 7000
    Belgium

    Site Not Available

  • Research Site

    Sofia, 1750
    Bulgaria

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2C8
    Canada

    Active - Recruiting

  • Research Site

    North Vancouver, British Columbia V7M 2H4
    Canada

    Active - Recruiting

  • Research Site

    Cambridge, Ontario N1R 6V6
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M6G 1M2
    Canada

    Active - Recruiting

  • Research Site

    Waterloo, Ontario N2T 0C1
    Canada

    Active - Recruiting

  • Research Site

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • Research Site

    Terrebonne, Quebec J6X 4P7
    Canada

    Site Not Available

  • Research Site

    Benesov, 256 01
    Czechia

    Active - Recruiting

  • Research Site

    Brandys nad Labem, 250 01
    Czechia

    Active - Recruiting

  • Research Site

    Broumov, 55001
    Czechia

    Active - Recruiting

  • Research Site

    Louny, 440 01
    Czechia

    Active - Recruiting

  • Research Site

    Bad Homburg, 61348
    Germany

    Active - Recruiting

  • Research Site

    Bad Oeynhausen, 32545
    Germany

    Active - Recruiting

  • Research Site

    Berlin, 12203
    Germany

    Active - Recruiting

  • Research Site

    Elsterwerda, 04910
    Germany

    Site Not Available

  • Research Site

    Erfurt, 99089
    Germany

    Site Not Available

  • Research Site

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Research Site

    Kaiserslautern, 67655
    Germany

    Active - Recruiting

  • Research Site

    Athens, 11527
    Greece

    Active - Recruiting

  • Research Site

    Attica, 11527
    Greece

    Active - Recruiting

  • Research Site

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • Research Site

    Budapest, 1148
    Hungary

    Active - Recruiting

  • Research Site

    Kalocsa, 6300
    Hungary

    Active - Recruiting

  • Research Site

    Nyíregyháza, 4400
    Hungary

    Active - Recruiting

  • Research Site

    Pécs, 7635
    Hungary

    Active - Recruiting

  • Research Site

    Szeged, 6724
    Hungary

    Active - Recruiting

  • Research Site

    Kota Bharu, 15586
    Malaysia

    Active - Recruiting

  • Research Site

    Muar, 84000
    Malaysia

    Active - Recruiting

  • Research Site

    Sarawak Miri, 98000
    Malaysia

    Active - Recruiting

  • Research Site

    Angeles City, 2009
    Philippines

    Active - Recruiting

  • Research Site

    Iloilo City, 5000
    Philippines

    Active - Recruiting

  • Research Site

    Białystok, 15-540
    Poland

    Site Not Available

  • Research Site

    Gdańsk, 80-214
    Poland

    Site Not Available

  • Research Site

    Kraków, 30-688
    Poland

    Site Not Available

  • Research Site

    Lodz, 91-002
    Poland

    Completed

  • Research Site

    Poznań, 61-848
    Poland

    Site Not Available

  • Research Site

    Warszawa, 04-628
    Poland

    Site Not Available

  • Research Site

    Riyadh, 11426
    Saudi Arabia

    Active - Recruiting

  • Research Site

    Brezno, 977 01
    Slovakia

    Active - Recruiting

  • Research Site

    Kosice, 04022
    Slovakia

    Active - Recruiting

  • Research Site

    Moldava nad Bodvou, 04501
    Slovakia

    Site Not Available

  • Research Site

    Svidník, 08901
    Slovakia

    Active - Recruiting

  • Research Site

    Cape Town, 7500
    South Africa

    Active - Recruiting

  • Research Site

    Durban, 4001
    South Africa

    Active - Recruiting

  • Research Site

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Research Site

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Research Site

    Oviedo, 33011
    Spain

    Site Not Available

  • Research Site

    Santa Coloma de Gramenet, 08923
    Spain

    Active - Recruiting

  • Research Site

    Terrassa (Barcelona), 08221
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46010
    Spain

    Active - Recruiting

  • Research Site

    New Taipei, 220
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Research Site

    Chiang Mai, 50200
    Thailand

    Active - Recruiting

  • Research Site

    Muang, 40002
    Thailand

    Active - Recruiting

  • Research Site

    Adana, 01060
    Turkey

    Active - Recruiting

  • Research Site

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Research Site

    Istanbul, 34668
    Turkey

    Site Not Available

  • Research Site

    Kahramanmaras, 46100
    Turkey

    Active - Recruiting

  • Research Site

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Research Site

    Odunpazarı, 26080
    Turkey

    Active - Recruiting

  • Research Site

    Canterbury, CT1 3NG
    United Kingdom

    Site Not Available

  • Research Site

    Corby, NN17 2UR
    United Kingdom

    Active - Recruiting

  • Research Site

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • Research Site

    Prescot, L35 5DR
    United Kingdom

    Site Not Available

  • Research Site

    Stockport, SK2 7JE
    United Kingdom

    Site Not Available

  • Research Site

    Swindon, SN3 6BB
    United Kingdom

    Active - Recruiting

  • Research Site

    Thetford, IP24 1JD
    United Kingdom

    Active - Recruiting

  • Research Site

    Weston-Super-Mare, BS24 7PR
    United Kingdom

    Active - Recruiting

  • Research Site

    Yate, BS37 4AX
    United Kingdom

    Active - Recruiting

  • Research Site

    Surprise, Arizona 85374
    United States

    Active - Recruiting

  • Research Site

    Huntington Park, California 90255
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Research Site

    Hollywood, Florida 33024
    United States

    Suspended

  • Research Site

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Research Site

    Lake Worth, Florida 33467
    United States

    Suspended

  • Research Site

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33606
    United States

    Site Not Available

  • Research Site

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Research Site

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Research Site

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Research Site

    Bronx, New York 10455
    United States

    Active - Recruiting

  • Research Site

    Greenville, North Carolina 27834
    United States

    Terminated

  • Research Site

    Kinston, North Carolina 28504
    United States

    Terminated

  • Research Site

    New Bern, North Carolina 28562
    United States

    Terminated

  • Research Site

    Wilmington, North Carolina 28401
    United States

    Terminated

  • Research Site

    Langhorne, Pennsylvania 19047
    United States

    Terminated

  • Research Site

    Brownsville, Texas 78526
    United States

    Active - Recruiting

  • Research Site

    Corpus Christi, Texas 78404
    United States

    Active - Recruiting

  • Research Site

    Lampasas, Texas 76550
    United States

    Suspended

  • Research Site

    Hanoi, 100000
    Vietnam

    Active - Recruiting

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Active - Recruiting

  • Research Site

    Hochiminh city, 700000
    Vietnam

    Active - Recruiting

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