NCT00653588已完成3 期
A 26-Week, Double Blind, Randomised, Multi-Centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin (40 mg) With Atorvastatin (80 mg) in Subjects With Hypercholesterolaemia and Coronary Heart Disease or CHD Risk Equivalents
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 主要终点
- To compare the efficacy of rosuvastatin with atorvastatin by assessing the percentage change from baseline to week 8 in LDL-C concentrations in subjects with hypercholesterolaemia and CHD or CHD risk equivalents.
研究概览
简要总结
The purpose of this study is to compare the effect of 8 weeks of treatment with Rosuvastatin with 8 weeks of treatment with Atorvastatin on low density lipoprotein cholesterol level in subjects with hypercholesterolemia and coronary heart disease (CHD) or at high risk of CHD..
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of CHD or clinical evidence of atherosclerosis or multiple risk factors that confer a high risk as defined in the protocol.
- •Fasting LDL-C concentrations at Visit 1 as defined in the protocol.
排除标准
- •History of statin induced serious side effects, or serious hypersensitivity reaction to other statins.
- •Subjects considered to be unstable by the investigator after the following events: a myocardial infarction (heart attack), unstable angina, myocardial revascularisation or another revascularisation procedure or a transient ischaemic attack (TIA) or stroke.
- •Severe congestive cardiac failure (as defined by the protocol - Appendix I).
- •Subjects awaiting a planned myocardial revascularisation prior to starting the study (i.e. planned prior to visit 1).
研究组 & 干预措施
1
Experimental
rosuvastatin (40 mg)
干预措施: Rosuvastatin (Drug)
2
Active Comparator
atorvastatin (80 mg)
干预措施: Atorvastatin (Drug)
结局指标
主要结局
To compare the efficacy of rosuvastatin with atorvastatin by assessing the percentage change from baseline to week 8 in LDL-C concentrations in subjects with hypercholesterolaemia and CHD or CHD risk equivalents.
次要结局
- To compare the efficacy of rosuvastatin with atorvastatin in modifying other lipids and lipoproteins at week 8
研究者
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