A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (Bax24)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

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).

Study Overview

• Status: Completed
• Conditions: Resistant Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: Baxdrostat

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1425AGC
    • Research Site
  • CABA, Argentina, C1061
    • Research Site
  • Capital Federal, Argentina, C1060ABN
    • Research Site
  • Córdoba, Argentina, X5003DCP
    • Research Site
  • Lanús Este, Argentina, B1824KAJ
    • Research Site
  • Rosario, Argentina, S2000PBJ
    • Research Site
  • San Miguel de Tucumán, Argentina, 4000
    • Research Site
  • San Vicente, Argentina, 5006
    • Research Site
• Australia
  • Clayton, Australia, 3168
    • Research Site
  • Perth, Australia, 6000
    • Research Site
• Belgium
  • Ghent, Belgium, 9000
    • Research Site
• Bulgaria
  • Sofia, Bulgaria, 1527
    • Research Site
  • Sofia, Bulgaria, 1618
    • Research Site
  • Sofia, Bulgaria, 1680
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • Research Site
  • British Columbia
    • North Vancouver, British Columbia, Canada, V7M 2H4
      • Research Site
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
      • Research Site
    • Toronto, Ontario, Canada, M6G 1M2
      • Research Site
    • Waterloo, Ontario, Canada, N2T 0C1
      • Research Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Research Site
    • Terrebonne, Quebec, Canada, J6X 4P7
      • Research Site
• Czechia
  • Benešov, Czechia, 256 01
    • Research Site
  • Brandýs nad Labem, Czechia, 250 01
    • Research Site
  • Broumov, Czechia, 55001
    • Research Site
  • Louny, Czechia, 440 01
    • Research Site
• Germany
  • Bad Homburg, Germany, 61348
    • Research Site
  • Berlin, Germany, 12203
    • Research Site
  • Frankfurt, Germany, 60590
    • Research Site
  • Kaiserslautern, Germany, 67655
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Attica, Greece, 11527
    • Research Site
  • Thessaloniki, Greece, 54642
    • Research Site
• Hungary
  • Budapest, Hungary, 1115
    • Research Site
  • Budapest, Hungary, 1148
    • Research Site
  • Kalocsa, Hungary, 6300
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Pécs, Hungary, 7635
    • Research Site
• Malaysia
  • Kota Bharu, Malaysia, 15586
    • Research Site
  • Muar town, Malaysia, 84000
    • Research Site
  • Sarawak Miri, Malaysia, 98000
    • Research Site
• Philippines
  • Angeles City, Philippines, 2009
    • Research Site
  • Iloilo City, Philippines, 5000
    • Research Site
• Poland
  • Bialystok, Poland, 15-540
    • Research Site
  • Gdansk, Poland, 80-214
    • Research Site
  • Krakow, Poland, 30-688
    • Research Site
  • Lodz, Poland, 91-002
    • Research Site
  • Poznan, Poland, 61-848
    • Research Site
  • Warsaw, Poland, 04-628
    • Research Site
• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • Research Site
  • Riyadh, Saudi Arabia, 11462
    • Research Site
• Slovakia
  • Brezno, Slovakia, 977 01
    • Research Site
  • Košice, Slovakia, 04022
    • Research Site
  • Svidník, Slovakia, 08901
    • Research Site
• South Africa
  • Cape Town, South Africa, 7500
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
• Spain
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Santa Coloma de Gramenet, Spain, 08923
    • Research Site
  • Terrassa (Barcelona), Spain, 08221
    • Research Site
  • Valencia, Spain, 46010
    • Research Site
• Taiwan
  • New Taipei City, Taiwan, 220
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taoyuan District, Taiwan, 333
    • Research Site
• Thailand
  • Bangkok, Thailand, 10330
    • Research Site
  • Bangkok, Thailand, 10400
    • Research Site
  • Bangkok, Thailand, 10700
    • Research Site
  • Chiang Mai, Thailand, 50200
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Research Site
  • Ankara, Turkey (Türkiye), 06230
    • Research Site
  • Kahramanmaraş, Turkey (Türkiye), 46100
    • Research Site
  • Kayseri, Turkey (Türkiye), 38039
    • Research Site
  • Odunpazari, Turkey (Türkiye), 26080
    • Research Site
• United Kingdom
  • Corby, United Kingdom, NN17 2UR
    • Research Site
  • London, United Kingdom, E1 1BB
    • Research Site
  • London, United Kingdom, W6 7HY
    • Research Site
  • Prescot, United Kingdom, L35 5DR
    • Research Site
  • Swindon, United Kingdom, SN3 6BB
    • Research Site
  • Thetford, United Kingdom, IP24 1JD
    • Research Site
  • Weston-super-Mare, United Kingdom, BS24 7PR
    • Research Site
  • Yate, United Kingdom, BS37 4AX
    • Research Site
• United States
  • Arizona
    • Surprise, Arizona, United States, 85374
      • Research Site
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Site
    • Lake Worth, Florida, United States, 33467
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Research Site
  • New York
    • The Bronx, New York, United States, 10455
      • Research Site
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Research Site
    • Jacksonville, North Carolina, United States, 28546
      • Research Site
    • Kinston, North Carolina, United States, 28504
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • Research Site
  • Texas
    • Brownsville, Texas, United States, 78526
      • Research Site
    • Corpus Christi, Texas, United States, 78404
      • Research Site
    • Lampasas, Texas, United States, 76550
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Hochiminh City, Vietnam, 700000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 mg baxdrostat; 2 mg baxdrostat administered orally, once daily (QD).	Drug: Baxdrostat; Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: • 2 mg per tablet.; Other Names: CIN-107
Placebo Comparator: Placebo; Placebo administered orally, once daily (QD)	Drug: Placebo; Placebo tablet matching baxdrostat, administered orally, once daily (QD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in ambulatory night-time average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average SBP at Week 12.	At Week 12
Change from baseline in ambulatory daytime average SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average SBP at Week 12.	At Week 12
Change from baseline in seated SBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated SBP at Week 12.	At Week 12
Participants achieving ambulatory 24-hour average SBP of < 130 mmHg	To assess the effect of treatment with baxdrostat 2 mg versus placebo on achieving ambulatory 24-hour average SBP < 130 mmHg at Week 12.	At Week 12
Change from baseline in ambulatory 24-hour average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory 24-hour average DBP at Week 12.	At Week 12
Change from baseline in ambulatory night-time average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory night-time average DBP at Week 12.	At Week 12
Change from baseline in the average ambulatory daytime average DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on ambulatory daytime average DBP at Week 12.	At Week 12
Change from baseline on seated DBP	To assess the effect of treatment with baxdrostat 2 mg versus placebo on seated DBP at Week 12.	At Week 12
Participants achieving a nocturnal SBP dipping of ≥ 10%	To assess the effect of treatment with baxdrostat 2 mg versus placebo in the nocturnal dipping pattern at Week 12.	At Week 12

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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. 2025 Sep 6. doi: 10.1681/ASN.0000000849. Online ahead of print. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 17, 2025
• Study Completion (Actual): August 17, 2025

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Blood pressure; Aldosterone; Resistant hypertension; Baxdrostat; CIN-107; Aldosterone synthase; Aldosterone synthase inhibitor
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: D6970C00009; 2023-507640-36-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing 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.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No