NCT00479713已完成3 期
A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment
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
- 618
- 主要终点
- Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
研究概览
简要总结
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is currently taking a statin medication for the treatment of high cholesterol
- •Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl
排除标准
- •Women who are pregnant or nursing, or women who intend to become pregnant
- •Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study
研究组 & 干预措施
1
Experimental
Arm 1: drug
干预措施: ezetimibe (+) simvastatin (Drug)
结局指标
主要结局
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
时间窗: Baseline and 6 weeks
Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
次要结局
- The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment(after 6 weeks of treatment)
研究者
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