NCT00525824已完成3 期
A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,743
- 试验地点
- 9
- 主要终点
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
研究概览
简要总结
The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20%
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
- •Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20
- •Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
- •Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow
排除标准
- •Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
- •Patients considered to be unstable by their physician after the following events:
- •a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation
结局指标
主要结局
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
时间窗: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value\*100
次要结局
- Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in TC/HDL-C After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment(Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward))
- Percent Change in LDL-C After 6 Weeks Monotherapy(Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward))
研究者
研究点 (9)
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