A Double-Blind, Randomised, Placebo-Controlled, Multicentre Study Evaluating the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 326
- 试验地点
- 94
- 主要终点
- Change from baseline in seated SBP at Week 12
研究概览
简要总结
The purpose of this study is to measure the efficacy and safety of baxdrostat in 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.
详细描述
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 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants must be ≥ 18 years old.
- •Mean seated SBP on automated office blood pressure measurement (AOBPM) ≥ 140 mmHg at Screening.
- •Fulfil at least 1 of the following 2 criteria:
- •uHTN subpopulation: have a stable regimen (≥ 4 weeks) 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.
- •rHTN subpopulation: have a stable regimen (≥ 4 weeks) 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.• Mean seated SBP on AOBPM ≥ 135 mmHg at Baseline.
排除标准
- •Mean seated SBP on AOBPM ≥ 170 mmHg.
- •Mean seated DBP on AOBPM ≥ 105 mmHg.
- •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.
研究组 & 干预措施
2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD)
干预措施: Baxdrostat (Drug)
1 mg baxdrostat
1 mg baxdrostat administered orally, once daily (QD).
干预措施: Baxdrostat (Drug)
placebo
Placebo administered orally, once daily (QD)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in seated SBP at Week 12
时间窗: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated SBP at Week 12
次要结局
- Change from RWD baseline (Week 24) in seated SBP at Week 32(At Week 32)
- Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM(At Week 12)
- Change from baseline in seated SBP at Week 12(At Week 12)
- Change from baseline in seated DBP at Week 12(At Week 12)
- Achieving seated SBP < 140 mmHg at Week 12(At Week 12)