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

Study acronym: BaxNoD
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Trial sites expanded: 0 → 51 locations
    • Start date changed from estimate of Sep 30, 2026 to Sep 17, 2026
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 1 of 13 entries
    • Study description revised
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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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.
Trial Details
NCT Number NCT07686120
Lead Sponsor AstraZeneca
Collaborators: Tigermed Consulting Co., Ltd
Conditions
(from sponsor)
Uncontrolled Hypertension
Enrollment 286 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov