A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,220
- 主要终点
- Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 45 years of age
- •Established cardiovascular disease A stable coronary disease B cerebrovascular disease C peripheral artery disease
- •Without established coronary disease D pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease E 3 or more risk factors for cardiovascular disease
- •Receiving evidence-based medical and dietary management of dyslipidemia
排除标准
- •Occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Concomitant treatment with any other drug raising HDL-C
- •Previous treatment with compounds targeting cholesteryl ester transfer protein (CETP)
研究组 & 干预措施
Dalcetrapib
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
干预措施: Background care (Other)
Dalcetrapib
Dalcetrapib 600 mg orally daily on a background of contemporary, guidelines-based medical care.
干预措施: dalcetrapib (Drug)
Placebo
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
干预措施: Background care (Other)
Placebo
Placebo orally daily, on a background of contemporary, guidelines-based medical care.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
时间窗: approximately 4 years
次要结局
- All cause mortality(approximately 4 years)
- Safety: Incidence of adverse events(approximately 4 years)
- Change in blood lipid and lipoprotein levels(from baseline to 12 months)