A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 20
- 主要终点
- Systolic Blood Pressure at office (mmHg)
研究概览
简要总结
This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.
详细描述
The primary objective of this study is to assess the effects of administration of firibastat (QGC001) 500 mg oral (po) twice daily (bis in die [bid]) on blood pressure (BP) over 12 weeks in subjects with uncontrolled primary HTN.
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
- •Men and women ≥18 years of age at Screening
- •Diagnosis of primary HTN for at least 6 months prior to Screening
排除标准
- •Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing's disease).
- •Automated office SBP >180 mmHg or DBP >110 mmHg at the Screening or Inclusion Visit (Visit 2, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
- •Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
研究组 & 干预措施
Firibastat
Capsules
干预措施: Firibastat (Drug)
Placebo
Matching capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Systolic Blood Pressure at office (mmHg)
时间窗: From Day 1 to Day 84
Automatic Office Blood Pressure measurement
次要结局
- Diastolic Blood Pressure at office (mmHg)(From Day 1 to Day 84)
- Mean 24-hour ambulatory Diastolic Blood Pressure (mmHg)(From Day 1 to Day 84)
- Mean 24-hour ambulatory Systolic Blood Pressure (mmHg)(From Day 1 to Day 84)