NCT06344104

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

A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Conditions

• Uncontrolled Hypertension
• Resistant Hypertension

Interventions

Type	Name	Description
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	Placebo tablet administered orally, once daily (QD).

Timeline

• Start date: 2024-04-08
• Primary completion: 2025-11-24
• Completion: 2026-04-03
• First posted: 2024-04-03
• Last updated: 2026-03-27

Locations

93 sites across 11 countries: Argentina, Australia, China, Hong Kong, India, Japan, Philippines, Russia, South Korea, Turkey (Türkiye), Vietnam