NCT00654537已完成3 期
A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia.
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
- 5,625
- 主要终点
- Percentage change in low density lipoprotein cholesterol.
研究概览
简要总结
To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin & simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.
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
- •Discontinuation of all previous lipid lowering therapy.
- •Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 & 3 for subjects not on lipid lowering therapy at Visit
- •Other lipid parameters as specified in the protocol.
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
- •Abnormal laboratory parameters as defined in the protocol.
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)
3
Active Comparator
Pravastatin
干预措施: Pravastatin (Drug)
4
Active Comparator
Simvastatin
干预措施: Simvastatin (Drug)
结局指标
主要结局
Percentage change in low density lipoprotein cholesterol.
时间窗: 4 & 6 weeks
次要结局
- Percentage change in other lipid parameters as defined by the protocol(6 weeks)
- Safety evaluation(6 weeks)
研究者
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