2023-505499-32-00招募中3 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 106
- 主要终点
- Change from baseline in seated systolic blood pressure for 2 mg baxdrostat.
研究概览
简要总结
To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at week 12. To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at week 12. Safety: To assess the safety and tolerability of baxdrostat versus placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 must 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 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 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.
结局指标
主要结局
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat.
Change from baseline in seated systolic blood pressure for 2 mg baxdrostat.
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat.
Change from baseline in seated systolic blood pressure for 1 mg baxdrostat.
Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments.
Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments.
次要结局
- Achieving seated SBP < 130 mmHg for 1 mg baxdrostat.
- Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat.
- Change from baseline in seated SBP for 2 mg baxdrostat.
- Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat.
- Achieving seated SBP < 130 mmHg for 2 mg baxdrostat.
- Change from baseline in seated SBP for 1 mg baxdrostat.
- Change from baseline in seated DBP for 1 mg baxdrostat.
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (106)
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