NCT00442897已完成4 期
Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 229
- 主要终点
- Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
研究概览
简要总结
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are naïve to lowering lipid agent
- •Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.
排除标准
- •Impaired kidney function
- •Increased liver enzyme levels
- •Pregnant women
- •Hypersensitivity to ezetimibe and other statin agents
研究组 & 干预措施
1
Experimental
干预措施: simvastatin (+) ezetimibe (Drug)
结局指标
主要结局
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
时间窗: After 6 weeks of treatment
Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)
次要结局
- Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment(After 12 weeks of the treatment)
研究者
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