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

NCT06168409 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: D6970C000092023-507640-36-00
• Study Type: interventional
• Target: 218
• Locations: 22 countries
• Sites: 102

Brief 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).

Conditions

Resistant Hypertension

Keywords

Hypertension; Resistant hypertension; Blood pressure; Baxdrostat; CIN-107; Aldosterone; Aldosterone synthase; Aldosterone synthase inhibitor

Outcome Measures

Primary Outcomes (1)

• Change from baseline in ambulatory 24-hour average SBP

  To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average SBP at Week 12.

  At Week 12

Secondary Outcomes (9)

• Change from baseline in ambulatory night-time average SBP

  At Week 12

• Change from baseline in ambulatory daytime average SBP

  At Week 12

• Change from baseline in seated SBP

  At Week 12

• Participants achieving ambulatory 24-hour average SBP of < 130 mmHg

  At Week 12

• Change from baseline in ambulatory 24-hour average DBP

  At Week 12

Study Arms (2)

2 mg baxdrostat

EXPERIMENTAL

2 mg baxdrostat administered orally, once daily (QD).

Drug: Baxdrostat

Placebo

PLACEBO COMPARATOR

Placebo administered orally, once daily (QD)

Drug: Placebo

Interventions

Baxdrostat DRUG

Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: • 2 mg per tablet.

Also known as: CIN-107

2 mg baxdrostat

Placebo DRUG

Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Placebo

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the 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 per central laboratory
• Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.

You may not qualify if:

• Mean seated SBP on AOBPM ≥ 170 mmHg.
• Mean seated DBP on AOBPM ≥ 110 mmHg.
• Serum sodium level \< 135 mmol/L at Screening, as per central laboratory.
• Participant has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
• New York Heart Association functional HF class IV.
• Persistent atrial fibrillation.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (102)

Research Site

Surprise, Arizona, 85374, United States

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Hollywood, Florida, 33024, United States

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Lake Worth, Florida, 33467, United States

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Port Charlotte, Florida, 33952, United States

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Fort Wayne, Indiana, 46804, United States

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Lexington, Kentucky, 40503, United States

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The Bronx, New York, 10455, United States

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Greenville, North Carolina, 27834, United States

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Jacksonville, North Carolina, 28546, United States

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Kinston, North Carolina, 28504, United States

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New Bern, North Carolina, 28562, United States

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Wilmington, North Carolina, 28401, United States

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Langhorne, Pennsylvania, 19047, United States

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Brownsville, Texas, 78526, United States

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Corpus Christi, Texas, 78404, United States

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Lampasas, Texas, 76550, United States

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CABA, C1061, Argentina

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CABA, C1425AGC, Argentina

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Capital Federal, C1060ABN, Argentina

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Córdoba, X5003DCP, Argentina

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Lanús Este, B1824KAJ, Argentina

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Rosario, S2000PBJ, Argentina

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San Miguel de Tucumán, 4000, Argentina

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San Vicente, 5006, Argentina

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Clayton, 3168, Australia

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Perth, 6000, Australia

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Ghent, 9000, Belgium

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Sofia, 1527, Bulgaria

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Sofia, 1618, Bulgaria

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Sofia, 1680, Bulgaria

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Edmonton, Alberta, T6G 2C8, Canada

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North Vancouver, British Columbia, V7M 2H4, Canada

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Cambridge, Ontario, N1R 6V6, Canada

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Toronto, Ontario, M6G 1M2, Canada

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Waterloo, Ontario, N2T 0C1, Canada

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Chicoutimi, Quebec, G7H 7K9, Canada

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Terrebonne, Quebec, J6X 4P7, Canada

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Benešov, 256 01, Czechia

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Brandýs nad Labem, 250 01, Czechia

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Broumov, 55001, Czechia

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Louny, 440 01, Czechia

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Bad Homburg, 61348, Germany

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Berlin, 12203, Germany

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Frankfurt, 60590, Germany

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Kaiserslautern, 67655, Germany

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Athens, 11527, Greece

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Attica, 11527, Greece

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Thessaloniki, 54642, Greece

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Budapest, 1115, Hungary

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Budapest, 1148, Hungary

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Kalocsa, 6300, Hungary

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Nyíregyháza, 4400, Hungary

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Pécs, 7635, Hungary

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Kota Bharu, 15586, Malaysia

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Muar town, 84000, Malaysia

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Sarawak Miri, 98000, Malaysia

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Angeles City, 2009, Philippines

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Iloilo City, 5000, Philippines

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Bialystok, 15-540, Poland

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Gdansk, 80-214, Poland

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Krakow, 30-688, Poland

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Lodz, 91-002, Poland

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Poznan, 61-848, Poland

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Warsaw, 04-628, Poland

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Riyadh, 11426, Saudi Arabia

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Riyadh, 11462, Saudi Arabia

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Brezno, 977 01, Slovakia

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Košice, 04022, Slovakia

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Svidník, 08901, Slovakia

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Cape Town, 7500, South Africa

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Durban, 4001, South Africa

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Barcelona, 08003, Spain

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Barcelona, 08036, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Santa Coloma de Gramenet, 08923, Spain

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Terrassa (Barcelona), 08221, Spain

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Valencia, 46010, Spain

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New Taipei City, 220, Taiwan

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Taipei, 11217, Taiwan

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Taoyuan District, 333, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Khon Kaen, 40002, Thailand

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Adana, 01060, Turkey (Türkiye)

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Ankara, 06230, Turkey (Türkiye)

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Kahramanmaraş, 46100, Turkey (Türkiye)

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Kayseri, 38039, Turkey (Türkiye)

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Odunpazari, 26080, Turkey (Türkiye)

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Corby, NN17 2UR, United Kingdom

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London, E1 1BB, United Kingdom

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London, W6 7HY, United Kingdom

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Prescot, L35 5DR, United Kingdom

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Swindon, SN3 6BB, United Kingdom

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Thetford, IP24 1JD, United Kingdom

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Weston-super-Mare, BS24 7PR, United Kingdom

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Yate, BS37 4AX, United Kingdom

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Hanoi, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Hochiminh City, 700000, Vietnam

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Related Publications (2)

• Azizi M, Brown JM, Dwyer JP, Flack JM, Jones ESW, Kurlyandskaya R, Li H, Birve F, Lihn AS, Perl S, Schlaich MP, Shibata H, Wang JG, Williams B; Bax24 investigators. Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026 Mar 7;407(10532):988-999. doi: 10.1016/S0140-6736(25)02549-8.

  PMID: 41794437 DERIVED

• Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.

  PMID: 40913594 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: March 1, 2024
• Primary Completion: August 17, 2025
• Study Completion: August 17, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CZ (4); ZA (2); TW (3); TU (5); TH (5); HU (5); PL (6); AR (8); ES (7); BE (1); AU (2); VN (3); US (16); DE (4); SL (3); GB (8); GR (3); PH (2); SA (2); BU (3); CA (7); MY (3)