A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- Safety and tolerability - especially the risk of bleeding
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.
详细描述
This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1 inhibitor. The total duration of individual study participation was 28 weeks (196 days). This included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（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
E5555 50 mg
Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
干预措施: E5555 (Drug)
E5555 50 mg
Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
干预措施: Placebo (Drug)
E5555 100 mg
Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
干预措施: E5555 (Drug)
E5555 100 mg
Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
干预措施: Placebo (Drug)
E5555 200 mg
Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
干预措施: E5555 (Drug)
E5555 200 mg
Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
干预措施: Placebo (Drug)
Placebo
Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability - especially the risk of bleeding
时间窗: 6 months
次要结局
- Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes(6 months)