CompletedPhase 3

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

United States796 participantsStarted 2023-11-22

Plain-language 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).

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator
✓. rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator

What they're measuring

Change from baseline in seated systolic blood pressure for 2 mg baxdrostat

Timeframe: At Week 12

Change from baseline in seated systolic blood pressure for 1 mg baxdrostat

Timeframe: At Week 12

Trial details

NCT IDNCT06034743

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-21

View on ClinicalTrials.gov More Uncontrolled Hypertension trials