A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in 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
- 218
- 试验地点
- 102
- 主要终点
- Least Square Mean Difference for Change From Baseline in Ambulatory 24-hour Average SBP at Week 12: Treatment Policy Strategy
研究概览
简要总结
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).
详细描述
This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg baxdrostat versus placebo, administered once a day (QD) orally, on the reduction of ambulatory SBP in participants with rHTN, defined as BP targets not being achieved in an individual despite the use of at least 3 antihypertensive agents of different classes (at maximum tolerated dose in the judgement of the Investigator), one of which is a diuretic.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 18 years old, at the time of signing the informed consent.
- •Mean seated SBP on AOBPM of ≥ 140 mmHg and < 170 mmHg at Screening.
- •Have a stable regimen 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, for at least 4 weeks prior to screening. Beta blockers used to treat other conditions (ie, migraine, HF, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.
- •Have eGFR ≥ 45 mL/min/1.73 m2 at Screening.
- •Serum potassium (K+) level ≥ 3.5 and < 5.0 mmol/L at Screening, determined as per central laboratory
- •Randomization Criteria: mean ambulatory SBP of ≥ 130 mmHg at randomisation.
排除标准
- •Mean seated SBP on AOBPM ≥ 170 mmHg.
- •Mean seated DBP on AOBPM ≥ 110 mmHg.
- •Serum sodium level < 135 mmol/L at Screening, as per central laboratory.
- •Participant 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 HF class IV.
- •Persistent atrial fibrillation.
研究组 & 干预措施
2 mg baxdrostat
2 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
Least Square Mean Difference for Change From Baseline in Ambulatory 24-hour Average SBP at Week 12: Treatment Policy Strategy
时间窗: Baseline to week 12
次要结局
- Change From Baseline in Ambulatory Night-time Average SBP (mmHg) at Week 12 LS Means(Baseline to week 12)
- Change From Baseline in Ambulatory Daytime Average SBP (mmHg) at Week 12(Baseline to week 12)
- Change From Baseline in Seated SBP (mmHg) at Week 12(Baseline to week 12)
- Achieving Ambulatory 24-hour Average SBP of < 130 mmHg at Week 12(Baseline to week 12)
- Change From Baseline in Ambulatory 24-hour Average DBP (mmHg) at Week 12(Baseline to week 12)
- Change From Baseline in Ambulatory Night-time Average DBP (mmHg) at Week 12(Baseline to week 12)
- Change From Baseline in Ambulatory Daytime Average DBP (mmHg) at Week 12(Baseline to week 12)
- Change From Baseline in Seated DBP (mmHg) at Week 12(Baseline to week 12)
- Achieving a Nocturnal SBP Dipping of >= 10% at Week 12(Baseline to week 12)
- Change from baseline in ambulatory night-time average SBP(At Week 12)
- Change from baseline in ambulatory daytime average SBP(At Week 12)
- Change from baseline in seated SBP(At Week 12)
- Participants achieving ambulatory 24-hour average SBP of < 130 mmHg(At Week 12)
- Change from baseline in ambulatory 24-hour average DBP(At Week 12)
- Change from baseline in ambulatory night-time average DBP(At Week 12)
- Change from baseline in the average ambulatory daytime average DBP(At Week 12)
- Change from baseline on seated DBP(At Week 12)
- Participants achieving a nocturnal SBP dipping of ≥ 10%(At Week 12)