NCT00654602已完成3 期
A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.
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
- 1,500
- 主要终点
- Reduction in low density lipoprotein cholesterol levels
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 level as defined by the protocol.
- •Fasting triglyceride level as defined by 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.
- •Blood lipid levels above the limits defined in the protocol.
- •Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
结局指标
主要结局
Reduction in low density lipoprotein cholesterol levels
时间窗: 12 weeks
次要结局
- Reduction in low density lipoprotein cholesterol levels(24 & 48 weeks)
- Safety: adverse events & abnormal laboratory markers(4 weekly until week 12 then 12 weekly thereafter.)
- Maintenance of lowered low density lipoprotein cholesterol level(Between week 12-48)
研究者
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