NCT00654173已完成3 期
A 12-Week, Randomized, Open-Label, 3 Arm Parallel Group, Multicenter, Phase IIIb Study Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin Achieving NCEP ATP III LDL-C Goals in High Risk Subjects With Hypercholesterolaemia in the Managed Care Setting.
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
- 4,444
- 主要终点
- Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin 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
- •Member of managed care plan for hypercholesterolemia
- •Fasting blood lipid levels as defined by the protocol
- •Diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving 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
Simvastatin
干预措施: Simvastatin (Drug)
3
Active Comparator
Atorvastatin
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percentage of subjects who achieve low density lipoprotein cholesterol goals while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin.
时间窗: 6 weeks
次要结局
- Percentage changes in other blood lipid levels while receiving treatment with rosuvastatin, compared to subjects receiving treatment with simvastatin or atorvastatin(6 & 12 weeks)
- Safety: adverse events & abnormal laboratory markers(6 & 12 weeks)
研究者
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