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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 796
- 试验地点
- 264
- 主要终点
- Change From Baseline in Seated Systolic Blood Pressure for 2 mg Baxdrostat
研究概览
简要总结
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).
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
- •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:
- •uHTN subpopulation: have a stable regimen 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 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
- •Randomisation Criterion:
- •Sitting systolic blood pressure on attended automated office blood pressure measurement of ≥ 135 mmHg at the Baseline Visit
排除标准
- •Mean sitting systolic blood pressure on attended automated office blood pressure measurement ≥ 170 mmHg
- •Mean seated diastolic blood pressure on attended automated office blood pressure measurement ≥ 110 mmHg
- •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
研究组 & 干预措施
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)
2 mg baxdrostat
2 mg baxdrostat administered orally, once daily (QD).
干预措施: Baxdrostat (Drug)
结局指标
主要结局
Change From Baseline in Seated Systolic Blood Pressure for 2 mg Baxdrostat
时间窗: At Week 12
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12. All available measurements were included, and missing data were multiply imputed.
Change From Baseline in Seated Systolic Blood Pressure for 1 mg Baxdrostat
时间窗: At Week 12
To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12. All available measurements were included, and missing data were multiply imputed.
次要结局
- Change From Randomised Withdrawal Baseline (Week 24) in Seated Systolic Blood Pressure (SBP) for 2 mg Baxdrostat(At Week 32)
- Change From Baseline in Seated SBP for 2 mg Baxdrostat in the Resistant Hypertension Subpopulation(At Week 12)
- Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 2 mg Baxdrostat(At Week 12)
- Number of Participants Who Achieved Seated SBP < 130 mmHg for 2 mg Baxdrostat(At Week 12)
- Change From Baseline in Seated SBP for 1 mg Baxdrostat in the Resistant Hypertension Subpopulation(At Week 12)
- Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 1 mg Baxdrostat(At Week 12)
- Number of Participants Who Achieved Seated SBP < 130 mmHg for 1 mg Baxdrostat(At Week 12)