NCT00395603终止3 期
Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 550
- 主要终点
- Percentage reduction in ldl-c at end-point after 6 weeks.
研究概览
简要总结
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.
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
- •Greater than 18 years of age
- •Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
- •Existing coronary heart disease and cholesterol > 4.0 mmol/l
排除标准
- •Uncontrolled diabetes
- •Elevated liver function tests
- •Elevated creatine kinase (ck)
- •Triglycerides (tg) > 4.5 mmol/l
- •Drug or alcohol dependency within 6 months prior to visit 1
- •Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
- •Woman of childbearing potential not using an acceptable method of birth control
- •Women who are pregnant or breast feeding
结局指标
主要结局
Percentage reduction in ldl-c at end-point after 6 weeks.
次要结局
未报告次要终点
研究者
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