CTIS2023-505499-32-00招募中1 期
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 - BaxHT
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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: 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., 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 baseline.
排除标准
- •Mean sitting systolic blood pressure on attended automated office blood pressure measurement = 170 mmHg at Randomisation., Mean seated diastolic blood pressure on attended automated office blood pressure measurement = 110 mmHg at Randomisation., 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.
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