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). - BaxHT

Ageishi Yuji0 个研究点目标入组 75 人开始时间: 2024年1月11日最近更新: 2024年4月23日

试验速览

暂无简介。

•1. Male or female participants must be >= 18 years old
•2. Mean sitting systolic blood pressure on automated office blood pressure measurement >= 140 mmHg and < 170 mmHg at Screening
•3. Fulfil at least 1 of the following 2 criteria:
•a) uHTN subpopulation: have a stable regimen 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
•b) rHTN subpopulation: have a stable regimen 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
•4. Estimated glomerular filtration rate >= 45 mL/min/1.73m2 at Screening
•5. Serum potassium (K+) level >= 3.5 and < 5.0 mmol/L at Screening
•6. Sitting systolic blood pressure on attended automated office blood pressure measurement of >= 135 mmHg at baseline

•1. Mean sitting systolic blood pressure on attended automated office blood pressure measurement >= 170 mmHg at Randomisation
•2. Mean seated diastolic blood pressure on attended automated office blood pressure measurement >= 110 mmHg at Randomisation
•3. Serum sodium level < 135 mmol/L at Screening
•4. 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
•5. New York Heart Association functional heart failure class IV at Screening
•6. Persistent atrial fibrillation

发起方

Ageishi Yuji