NCT00654485已完成3 期
A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%
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
- 940
- 主要终点
- Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
研究概览
简要总结
The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.
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
- Double
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
- •Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
- •Fasting low density lipoprotein cholesterol level of > 130 mg/dL.
- •Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
- •Not previously taken statins.
排除标准
- •The use of lipid lowering drugs or dietary supplements after Visit 1
- •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 lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.
时间窗: At 6 & 12 weeks
次要结局
- Modification of other lipids and lipoproteins(At 6 & 12 weeks)
- Modification of insulin resistance, inflammatory markers & glucose metabolism(At 6 & 12 weeks)
- Safety: adverse events & abnormal laboratory markers(At 6 & 12 weeks)
研究者
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