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

Active, not recruiting

• Conditions: Uncontrolled Hypertension; Resistant Hypertension
• Interventions: Drug: Baxdrostat; Drug: Placebo

• Registration Number: NCT06034743
• Lead Sponsor: AstraZeneca

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-13
• Study Start: 2023-11-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-06-05
• Study Completion: 2025-10-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 796

Inclusion Criteria

• Male or female participants must be ≥ 18 years old

• Mean sitting systolic blood pressure on automated office blood pressure measurement ≥ 140 mmHg and < 170 mmHg at Screening

• Fulfil at least 1 of the following 2 criteria:

  1. 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
  2. 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

• Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening

• Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening

• Randomisation Criterion:

• Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit

Exclusion Criteria

• Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
• Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
• Serum sodium level < 135 mmol/L at Screening
• Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation
• New York Heart Association functional heart failure class IV at Screening
• Persistent atrial fibrillation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 mg baxdrostat	Baxdrostat	1 mg baxdrostat administered orally, once daily (QD).
Placebo	Placebo	Placebo administered orally, once daily (QD).
2 mg baxdrostat	Baxdrostat	2 mg baxdrostat administered orally, once daily (QD).

Primary Outcome Measures

Name	Time	Method
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat	At Week 12	To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat	At Week 12	To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12

Secondary Outcome Measures

Name	Time	Method
Change from baseline in seated SBP for 2 mg baxdrostat	At Week 12	To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation
Achieving seated SBP < 130 mmHg for 2 mg baxdrostat	At Week 12	To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP \< 130 mmHg at Week 12
Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat	At Week 12	To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12
Change from baseline in seated DBP for 1 mg baxdrostat	At Week 12	To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12
Change from baseline in seated SBP for 1 mg baxdrostat	At Week 12	To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation
Achieving seated SBP < 130 mmHg for 1 mg baxdrostat	At Week 12	To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP \< 130 mmHg at Week 12
Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat	At Week 32	To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal

Trial Locations

Locations (1)

Research Site; 🇻🇳 Hochiminh city, Vietnam