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

• Status: Recruiting
• Trial end date: 2025-10-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

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