NCT01323153已完成3 期
A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
研究概览
简要总结
This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.
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
- •Patients admitted to the hospital for acute coronary syndrome (ACS)
- •Patients receiving guideline-based medical and dietary management of dyslipidemia
排除标准
- •Symptomatic congestive heart failure (NYHA Class III or IV)
- •Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Severe anemia
- •Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Dalcetrapib
Experimental
干预措施: dalcetrapib (Drug)
结局指标
主要结局
Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
时间窗: 4 weeks
次要结局
- Safety: Incidence of Adverse Events(24 weeks)
- Percent Change From Baseline in Lipoprotein Levels(20 weeks)
- Percent Change From Baseline in Blood Lipid Levels(20 weeks)
- Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971(4 weeks)
- Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment(20 weeks)
- Percent Change From Baseline in Apolipoprotein Levels(20 weeks)
研究者
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