A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS1410 Tablets in the Treatment of Patients With Primary Aldosteronism.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change from baseline in seated Systolic Blood Pressure (SBP) at Week 12
研究概览
简要总结
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of QLS1410 versus placebo, on the reduction of Seated Blood Pressure (SBP) in participants ≥ 18 years of age with Primary Aldosteronism (PA) with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.
QLS1410 (or placebo) will be administered once daily, up-titrated after 2 weeks or 4 weeks based on clinical response and tolerability.
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 of age
- •Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines.
- •Participants willing and able to cease dosing of mineralocorticoid receptor antagonist (MRA) or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.
- •eGFR ≥ 45 mL/min/1.73m2 at Screening
- •Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization
排除标准
- •Had undergone surgery for adrenal adenoma in the past or planned to receive surgical treatments such as adrenalectomy, renal sympathetic denervation, or adrenal ablation during the course of the study.
- •Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
- •Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.
研究组 & 干预措施
QLS1410
干预措施: QLS1410 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 12
时间窗: at week 12
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 12
次要结局
未报告次要终点