A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

Overview

The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian 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.

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 Asian participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 140 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).

Eligibility

Inclusion Criteria:

• Male or female participants must be ≥ 18 years old
• Mean siSBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg and < 170 mmHg at Screening.
• Fulfil at least 1 of the following 2 criteria:
  1. uHTN subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one should be a diuretic), at maximum tolerated dose in the judgement of the Investigator
  2. rHTN subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one should 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
• Mean siSBP on AOBPM ≥ 140 mmHg at Baseline.

Exclusion Criteria:

• Mean siSBP on AOBPM ≥ 170 mmHg at randomisation
• Mean siDBP on AOBPM ≥ 105 mmHg at randomization• Serum sodium level (Na+) < 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
• NYHA functional heart failure class IV at Screening