A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxAsia)

April 20, 2026 updated by: AstraZeneca

A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahía Blanca, Argentina, 8000
        • Research Site
      • CABA, Argentina, C1426
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1419AHL
        • Research Site
      • San Miguel de Tucumán, Argentina, T4000ICL
        • Research Site
      • San Nicolás de los Arroyos, Argentina, B2900DPA
        • Research Site
  • Australia
      • Coffs Harbour, Australia, 02450
        • Research Site
      • Gosford, Australia, 2250
        • Research Site
      • Hoppers Crossing, Australia, 3029
        • Research Site
      • Ipswich, Australia, 4305
        • Research Site
  • China
      • Baotou, China, 014010
        • Research Site
      • Beijing, China, 100029
        • Research Site
      • Beijing, China, 100044
        • Research Site
      • Bengbu, China, 233004
        • Research Site
      • Changde, China, 415000
        • Research Site
      • Changsha, China, 410015
        • Research Site
      • Changsha, China, 430033
        • Research Site
      • Changzhou, China, 272100
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Chongqing, China, 400010
        • Research Site
      • Chongqing, China, 400042
        • Research Site
      • Chongqing, China, 400014
        • Research Site
      • Deyang, China, 618000
        • Research Site
      • Guangzhou, China, 510100
        • Research Site
      • Hangzhou, China, 310014
        • Research Site
      • Ha’erbin, China, 150001
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Heze, China, 274099
        • Research Site
      • Jiujiang, China, 332000
        • Research Site
      • Luoyang, China, 471000
        • Research Site
      • Meihekou, China, 135022
        • Research Site
      • Nanchang, China, 330009
        • Research Site
      • Nanchong, China, 637900
        • Research Site
      • Nanjing, China, 210009
        • Research Site
      • Panjin, China, 124009
        • Research Site
      • Sanya, China, 572000
        • Research Site
      • Shanghai, China, 200025
        • Research Site
      • Shanghai, China, 200040
        • Research Site
      • Shenyang, China, 110016
        • Research Site
      • Shenyang, China, 110004
        • Research Site
      • Taiyuan, China, 030024
        • Research Site
      • Tianjin, China
        • Research Site
      • Tianjin, China, 300457
        • Research Site
      • Wuhan, China, 430022
        • Research Site
      • Wuhan, China, 430060
        • Research Site
      • Wuhan, China, 430010
        • Research Site
      • Xianyang, China, 712000
        • Research Site
      • Xianyang, China, 750004
        • Research Site
      • Xuzhou, China, 221000
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Yinchuan, China, 750001
        • Research Site
      • Zigong, China, 643021
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • Hong Kong, Hong Kong, 00000
        • Research Site
  • India
      • Bangalore, India, 560 092
        • Research Site
      • Belagavi, India, 590016
        • Research Site
  • Japan
      • Chūōku, Japan, 103-0027
        • Research Site
      • Chūōku, Japan, 260-0804
        • Research Site
      • Hamamatsu, Japan, 430-0929
        • Research Site
      • Kagoshima, Japan, 890-8520
        • Research Site
      • Koga-shi, Japan, 306-0232
        • Research Site
      • Meguro-ku, Japan, 153-0051
        • Research Site
      • Minatoku, Japan, 108-0073
        • Research Site
      • Minokamo Shi, Japan, 505-8510
        • Research Site
      • Osaka, Japan, 530-8480
        • Research Site
      • Toshima-ku, Japan, 171-0014
        • Research Site
      • Tsukuba, Japan, 305-0861
        • Research Site
      • Yokohama, Japan, 236-0004
        • Research Site
  • Philippines
      • Iloilo City, Philippines, 5000
        • Research Site
      • Quezon City, Philippines, 1112
        • Research Site
  • Russia
      • Ivanovo, Russia, 153012
        • Research Site
      • Moscow, Russia, 119991
        • Research Site
      • Moscow, Russia, 121552
        • Research Site
      • Moscow, Russia, 111539
        • Research Site
      • Moscow, Russia, 129327
        • Research Site
      • Saint Petersburg, Russia, 195067
        • Research Site
      • Saint Petersburg, Russia, 197341
        • Research Site
  • South Korea
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 04763
        • Research Site
      • Seoul, South Korea, 05505
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Research Site
      • Ankara, Turkey (Türkiye), 5000
        • Research Site
      • Cordaleo, Turkey (Türkiye), 35575
        • Research Site
      • Edirne, Turkey (Türkiye), 22030
        • Research Site
      • Kahramanmaraş, Turkey (Türkiye), 46100
        • Research Site
      • Kayseri, Turkey (Türkiye), 38039
        • Research Site
      • Kocaeli, Turkey (Türkiye), 41380
        • Research Site
      • Mersin, Turkey (Türkiye), 33343
        • Research Site
  • Vietnam
      • Can Tho, Vietnam, 900000
        • Research Site
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Hochiminh, Vietnam, 70000
        • Research Site
      • Hochiminh City, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female participants must be ≥ 18 years old.
  • Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.

  • Fulfil at least 1 of the following 2 criteria:

    1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
    2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) 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.
  • Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening.
  • Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.

Exclusion Criteria:

  • Mean seated SBP on AOBPM ≥ 170 mmHg.
  • Mean seated DBP on AOBPM ≥ 105 mmHg.
  • Serum sodium level (Na+) < 135 mmol/L at Screening.
  • 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.
  • NYHA functional heart failure class IV at Screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 mg baxdrostat
1 mg baxdrostat administered orally, once daily (QD).
Drug: Baxdrostat

Baxdrostat tablet administered orally, once daily (QD). Unit dose strength:

  • 1 mg per tablet for 1mg baxdrostat Arm
  • 2 mg per tablet for 2mg baxdrostat Arm
Other Names:
  • CIN-107
Experimental: 2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD)
Drug: Baxdrostat

Baxdrostat tablet administered orally, once daily (QD). Unit dose strength:

  • 1 mg per tablet for 1mg baxdrostat Arm
  • 2 mg per tablet for 2mg baxdrostat Arm
Other Names:
  • CIN-107
Placebo Comparator: placebo
Placebo administered orally, once daily (QD)
Drug: Placebo
Placebo tablet administered orally, once daily (QD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in seated SBP at Week 12
Time Frame: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12
At Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
Time Frame: At Week 12
To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12
At Week 12
Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM
Time Frame: At Week 12
To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12
At Week 12
Change from baseline in seated SBP at Week 12
Time Frame: At Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12
At Week 12
Change from RWD baseline (Week 24) in seated SBP at Week 32
Time Frame: At Week 32
To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at 8 weeks after randomised withdrawal
At Week 32
Change from baseline in seated DBP at Week 12
Time Frame: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated DBP at Week 12
At Week 12
Achieving seated SBP < 140 mmHg at Week 12
Time Frame: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on achieving seated SBP < 140 mmHg at Week 12
At Week 12
Change from baseline in seated DBP at Week 12
Time Frame: At Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated DBP at Week 12
At Week 12
Achieving seated SBP < 140 mmHg at Week 12
Time Frame: At Week 12
To assess the effect of 1 mg baxdrostat versus placebo on achieving seated SBP < 140 mmHg at Week 12
At Week 12
Change from baseline in seated SBP at Week 12
Time Frame: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup
At Week 12
Change from baseline in seated SBP at Week 12
Time Frame: At Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated SBP at Week 12 in the rHTN subgroup
At Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to week 54
To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI)
Up to week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Actual)

November 24, 2025

Study Completion (Actual)

April 3, 2026

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6970C00008

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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