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
NCT06344104 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326
Last updated 2026-04-21
Summary
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.
Conditions
- Uncontrolled Hypertension
- Resistant Hypertension
Interventions
- DRUG
-
Baxdrostat
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
- DRUG
-
Placebo tablet administered orally, once daily (QD).
Sponsors & Collaborators
- 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
- 2024-04-08
- Primary Completion
- 2025-11-24
- Completion
- 2026-04-03
Countries
- Argentina
- Australia
- China
- Hong Kong
- India
- Japan
- Philippines
- Russia
- South Korea
- Turkey (Türkiye)
- Vietnam
Study Locations
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