A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 162
- 试验地点
- 56
- 主要终点
- Change from baseline in six-minute walk distance (6MWD) evaluated after 12 weeks of treatment
研究概览
简要总结
This Phase 2, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study will compare the efficacy, safety, and tolerability of cicletanine hydrochloride (HCl) to placebo in subjects with PAH. Study drug will be administered alone, or on the background of stable PAH therapy. The study will consist of 3 periods: a screening period, a 12-week placebo-controlled treatment period, and a long-term, blinded extension period.
详细描述
The primary objective of this study is to compare the change in exercise capacity following treatment with cicletanine HCl or placebo in subjects with PAH.
The secondary objectives of this study are:
- To compare the change in other clinical measures of PAH following treatment with cicletanine HCl or placebo in subjects with PAH
- To compare the safety and tolerability of cicletanine HCl to placebo in subjects with PAH Additionally, the long-term safety, tolerability, and efficacy of cicletanine HCl treatment will be evaluated.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cicletanine 150 mg QD
Cicletanine 150 mg administered once daily (QD)
干预措施: Cicletanine (Drug)
Cicletanine 150 mg BID
Cicletanine 150 mg administered twice daily (BID)
干预措施: Cicletanine (Drug)
Cicletanine 300 mg QD
Cicletanine 300 mg administered once daily (QD)
干预措施: Cicletanine (Drug)
Placebo
Placebo to match cicletanine administered once daily
干预措施: Cicletanine (Drug)
Placebo
Placebo to match cicletanine administered once daily
干预措施: Cicletanine Placebo (Drug)
结局指标
主要结局
Change from baseline in six-minute walk distance (6MWD) evaluated after 12 weeks of treatment
时间窗: Baseline to Week 12
次要结局
- Change from baseline in BDI, WHO Functional Class, BNP, cardiac hemodynamics and SF-36 physical functioning scale following 12 weeks of treatment. In addition, time to clinical worsening (TTCW) will be evaluated.(Baseline to Week 60)