BENITIONSClinical Trial Intelligence

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

Phase 3 Completed NCT06034743

ConditionUncontrolled Hypertension, Resistant Hypertension
PhasePhase 3
SponsorAstraZeneca
StatusCompleted
Enrollment796 participants
InterventionsBaxdrostat
Start dateNov 22, 2023
Completion dateMay 21, 2025
Results postedJul 30, 2026

Summary

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

Change From Baseline in Seated Systolic Blood Pressure for 2 mg Baxdrostat

At Week 12 · mmHg

Double-Blind Treatment Period Weeks 0-12 Baxdrostat 2mg-15.7 ± 1.0 mmHg
Double-Blind Treatment Period Weeks 0-12 Placebo-5.8 ± 1.0 mmHg
p-value<0.0001
Least Square Mean Difference-9.8 (95% CI -12.6–-7.0)

Change From Baseline in Seated Systolic Blood Pressure for 1 mg Baxdrostat

At Week 12 · mmHg

Double-Blind Treatment Period Weeks 0-12 Baxdrostat 1mg-14.5 ± 1.0 mmHg
Double-Blind Treatment Period Weeks 0-12 Placebo-5.8 ± 1.0 mmHg
p-value<0.0001
Least Square Mean Difference-8.7 (95% CI -11.5–-5.8)

Open in BENITIONS View on ClinicalTrials.gov

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