NCT00654225已完成3 期
A 6-Week, Randomized,Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin and Atorvastatin in the Treatment of Hypercholesterolaemia in South Asian Subjects.
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
- 入组人数
- 2,340
- 主要终点
- Low density lipoproteins cholesterol levels
研究概览
简要总结
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in South Asian subjects with hypercholesterolemia.
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
- •Fasting low density lipoprotein & triglyceride levels as defined by the protocol.
- •Self described South Asian race
- •Subjects with coronary heart disease or at high risk of coronary heart disease.
排除标准
- •The use of lipid lowering drugs or dietary supplements after Visit
- •Active arterial disease eg Unstable angina, or recent arterial surgery
- •Blood lipid levels above the limits defined in the protocol.
- •Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
研究组 & 干预措施
1
Experimental
Rosuvastatin
干预措施: Rosuvastatin (Drug)
2
Active Comparator
Atorvastatin
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Low density lipoproteins cholesterol levels
时间窗: 6 weeks
次要结局
- Safety: adverse events & abnormal laboratory markers(6 weeks)
研究者
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