A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
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).
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:
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:
CABA, C1119ACN, Argentina
CABA, C1425HFA, Argentina
Ciudad de Buenos Aires, AR-CP 1221, Argentina
Adachi-ku, 121-0815, Japan
Koga-shi, 306-0232, Japan
Tsuchiura-shi, 300-0062, Japan
Yufu-shi, 879-5593, Japan
Sarawak Miri, 98000, Malaysia
Kwadwesi, 6201, South Africa
Yung Kang City, 71044, Taiwan
Hochiminh City, 700000, Vietnam