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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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