NCT00329173已完成3 期
A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) With Atorvastatin (20 mg) in Subjects With Hypercholesterolaemia and Either a History of CHD or Clinical Evidence of 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
- 1,000
- 主要终点
- Reduction in LDL-c after 6 weeks
研究概览
简要总结
To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks 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
- •Male or female 18 or over.
- •A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score > 20% for CHD as described in NCEP ATP III guidelines1.
排除标准
- •History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
- •Pregnancy
- •History of homozygous familial hypercholesterolaemia.
结局指标
主要结局
Reduction in LDL-c after 6 weeks
次要结局
- Changes in other lipids and lipoproteins
- Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C
- Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.
- Comparison of cost effectiveness and also safety
研究者
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