NCT06168409

A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).

Detailed description

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
DRUG	Baxdrostat	Baxdrostat tablet administered orally, once daily (QD). Unit dose strength: • 2 mg per tablet.
DRUG	Placebo	Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-08-17
• Completion: 2025-08-17
• First posted: 2023-12-13
• Last updated: 2026-02-06

Locations

102 sites across 22 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, Malaysia, Philippines, Poland, Saudi Arabia, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study