NCT07489612Enrolling By Invitation2 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of QLS1410 in Participants With Uncontrolled Hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change from baseline in mean seated systolic blood pressure (SBP) at week 12
研究概览
简要总结
The goal of this clinical trial is to measure the efficacy and safety of QLS1410 in participants with uncontrolled hypertension (uHTN) or treatment-resistant hypertension (rHTN). The main objective is to compare the difference in systolic blood pressure（SBP) change from baseline at Week 12 of treatment between participants receiving QLS1410 tablets and participants receiving placebo tablets.
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 ≥ 140 mmHg at Screening and at Baseline..
- •Fulfil at least 1 of the following 2 criteria:
- •Uncontrolled Hypertension (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.
- •Resistant Hypertension (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.
排除标准
- •Mean seated systolic blood pressure (SBP)≥ 180 mmHg.
- •Mean seated diastolic blood pressure (DBP)≥ 110 mmHg.
- •Estimated glomerular filtration rate < 45 mL/min/1.73m
- •Serum potassium (K+) level <3.5 and ≥ 5.0 mmol/L.
- •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.
结局指标
主要结局
Change from baseline in mean seated systolic blood pressure (SBP) at week 12
时间窗: At week 12
To assess the effect of QLS1410 versus placebo on the mean seated systolic blood pressure (SBP) at week 12
次要结局
未报告次要终点
研究者
研究点 (1)
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