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

Conditions

• Resistant Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Mar 1, 2024

Status verified

Feb 2026

Primary completion

Aug 17, 2025

Completion

Aug 17, 2025

Study Design

Enrollment

218 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 2 mg baxdrostat
  2 mg baxdrostat administered orally, once daily (QD).
• Placebo Comparator: Placebo
  Placebo administered orally, once daily (QD)

Primary Outcome Measure

Change from baseline in ambulatory 24-hour average SBP [ Time Frame: At Week 12 ]

Locations (16)

Related coverage on Hipa.ai

• Baxdrostat Phase 3 Trial for Resistant Hypertension Reaches Primary Completion
  Baxdrostat · Aug 17, 2025 · ClinicalTrials.gov

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