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A Phase IIIb Study to Investigate the Effect of Baxdrostat in Chinese Participants With Uncontrolled Hypertension.

NCT07686120 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2026-07-07

No results posted yet for this study

Summary

This is a Phase IIIb, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of baxdrostat 2mg versus placebo, administered QD orally, on the reduction of ambulatory 24-hour average SBP in participants with uHTN.

Consenting participants will be screened within 4 weeks and will subsequently enter a 4-week run-in period with placebo. Thereafter, participants will be randomised in a 1:1 ratio to receive one of the following 2 treatments QD, during a 12-week double-blind treatment period:

baxdrostat 2mg Placebo The randomisation will be stratified by mean ambulatory SBP at baseline (\<140 mmHg, ≥140 mmHg) and the number of background antihypertensive medication classes (2, ≥3) at baseline.

During the 12-week double-blind treatment period, participants should remain on their background antihypertensive medication. Doses of background medications should not be changed during this period unless participants experience SBP \< 100 mmHg with symptoms of hypotension. Rescue therapy is permitted if the SBP or DBP exceeds 170 or 105 mmHg, respectively. The choice of rescue therapy is based on the Investigator's best clinical judgement; however, the use of potassium-sparing diuretics and MRAs are prohibited.After completing the 12 weeks double-blind treatment period participants will complete a 2-week safety follow-up period. The total duration of study participation will be of approximately 22 weeks.

Conditions

Interventions

DRUG

baxdrostat 2mg

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

DRUG

Placebo 2mg

Placebo 2mg tablet administered orally, once daily (QD).

Sponsors & Collaborators

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-02-09
Completion
2028-02-09
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686120 on ClinicalTrials.gov