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

Sponsor
AstraZeneca
Study ID
NCT06344104
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 8, 2024
Status verified
Apr 2026
Primary completion
Nov 24, 2025
Completion
Apr 3, 2026

Study Design

Enrollment
326 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2 mg baxdrostat
    2 mg baxdrostat administered orally, once daily (QD)
  • Experimental: 1 mg baxdrostat
    1 mg baxdrostat administered orally, once daily (QD).
  • Placebo Comparator: placebo
    Placebo administered orally, once daily (QD)

Primary Outcome Measure

Change from baseline in seated SBP at Week 12 [ Time Frame: At Week 12 ]

Related coverage on Hipa.ai

Related Studies