NCT00157924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 Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome
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
- 190
- 主要终点
- LDL-C lowering efficacy
研究概览
简要总结
An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.
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
- •Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal
排除标准
- •Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
研究组 & 干预措施
2
Active Comparator
- atorvastatin 10mg
干预措施: atorvastatin (Drug)
1
Experimental
- simvastatin/ezetimibe 10/20mg
干预措施: simvastatin (+) ezetimibe (Drug)
结局指标
主要结局
LDL-C lowering efficacy
时间窗: 6 weeks
次要结局
- Safety(6 weeks)
研究者
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