A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT07007793
Phase
PHASE3
Status
Recruiting
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Conditions

  • Primary Hyperaldosteronism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baxdrostat — DRUG
    Baxdrostat tablet administered orally, once daily (QD).
  • Placebo — DRUG
    Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Study Details

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 180 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.

Key Dates

Start date
Aug 7, 2025
Status verified
Apr 2026
Primary completion
Feb 18, 2028
Completion
Feb 18, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baxdrostat
    Baxdrostat administered orally, once daily (QD).
  • Placebo Comparator: Placebo
    Matching placebo administered orally, once daily (QD).

Primary Outcome Measure

Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 [ Time Frame: At week 8 ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90048-
Research SiteSan FranciscoCalifornia94110-
Research SiteFarmingtonConnecticut06030-
Research SiteChicagoIllinois60611-
Research SiteSpringfieldIllinois62702-
Research SiteBaltimoreMaryland21287-
Research SiteBostonMassachusetts02111-
Research SiteBostonMassachusetts02115-
Research SiteAnn ArborMichigan48109-
Research SiteRochesterMinnesota55902-
Research SiteOlive BranchMississippi38654-
Research SiteKansas CityMissouri64151-
Research SiteNew YorkNew York10065-
Research SiteClevelandOhio44195-
Research SiteColumbusOhio43210-
Research SitePortlandOregon97239-
Research SiteBethlehemPennsylvania18017-
Research SitePhiladelphiaPennsylvania19104-
Research SiteColumbiaSouth Carolina29203-
Research SiteBrownsvilleTexas78526-
Research SiteDallasTexas75390-

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