NCT00239330已完成3 期
An Open-label, Randomised, Multi-centre, Phase IIIb, Parallel Group Study to Compare the Efficacy and Safety of Rosuvastatin and Atorvastatin in Subjects With Type IIa and IIb 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
- 824
- 试验地点
- 26
- 主要终点
- The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.
研究概览
简要总结
The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.
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
- •Male or female subjects, age > 18 years
- •Primary hypercholesterolaemia with CV risk > 20% (as defined in European Guidelines ) and/or type II diabetes and/or a history of CHD or other established atherosclerotic disease. Subjects may be lipid-lowering therapy naïve or have been treated for min. 4 weeks with a 'start' dose of any lipid-lowering therapy, which was ineffective.
- •Naïve subjects must have completed 12-weeks dietary counselling before this visit.
排除标准
- •Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
- •Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria
- •Serious or unstable medical condition
- •Statin contraindication
结局指标
主要结局
The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.
次要结局
- To compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS TC treatment goal after 12 weeks of therapy.
- To compare the percentage change in LDL-C, TC, HDL-C and TG from pre-dose rosuvastatin 10 mg / atorvastatin 10 mg (week 0) and at 12 weeks. This will be performed separately for the switched and the naïve subjects.
- To compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg in modifying lipids (Non-HDL-C, TC/HDL-C, LDL-C/ HDL-C, non-HDL-C/HDL-C) at week 12. This will be performed separately for the switched and the naïve subjects.
- To compare rosuvastatin 10 mg with atorvastatin 10 mg after 12 & 24 weeks of treatment with respect to the incidence & severity of adverse events & abnormal laboratory values.
研究者
研究点 (26)
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