NCT00166504已完成4 期
A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia
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
- 203
- 主要终点
- LDL-C Lowering Efficacy
研究概览
简要总结
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hypercholesterolemia
- •LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
- •National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline
排除标准
- •Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe
研究组 & 干预措施
Vytorin
Experimental
Ezetimibe 10 mg/Simvastatin 20 mg
干预措施: ezetimibe (+) simvastatin (Drug)
Atorvastatin
Active Comparator
Atorvastatin 10 mg
干预措施: atorvastatin (Drug)
结局指标
主要结局
LDL-C Lowering Efficacy
时间窗: 6 weeks
LDL-C = low density lipoprotein cholesterol, measured in mg/dl.
次要结局
未报告次要终点
研究者
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