Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.

Study acronym: BaxPA
StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
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Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites reduced: 89 → 76 locations
    • Final enrollment: 212 participants (planned 250)
    • Primary completion date: Aug 13, 2027 to Jul 27, 2027
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints revised (6)
    • Study title expanded, about 13 words
  2. Primary completion moved earlier from Feb 18, 2028 to Aug 13, 2027v7 Show 4 more changesShow less
    • Study completion pushed from Feb 18, 2028 to Aug 14, 2028
    • Secondary endpoints revised (6)
    • Primary endpoints revised (2)
    • Site details revised at 67 of 89 sites
  3. Enrollment increased: 180 → 250 participants
    • Site details revised at 13 of 89 sites
    v6
  4. Study sites: 88 to 89v5
  5. Eligibility criteria expanded, about 24 words
    • Secondary endpoints revised (6)
    • Site details revised at 29 of 88 sites
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 82 to 88v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 22 to 82
    v2
  1. 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
729 trials monitored
See 62 trials at risk
Parent study: This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 250 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries. Sub-study: The purpose of this study is to describe PA disease characteristics after completing baxdrostat treatment in participants with PA. Investigational medicinal product (IMP) will not be administered during the substudy. Study details include: * The study duration will be up to 70 ± 9 weeks. * The visits will be at Week 13 (Visit 2), Week 26 (Visit 3), Week 52 (Visit 4), and up to Week 70 (Visit 5).
Trial Details
NCT Number NCT07007793
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 Primary Hyperaldosteronism
Related terms Hyperaldosteronism
Enrollment 212 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov