NCT00654446已完成3 期
A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia
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
- 442
- 主要终点
- Development of Proteinuria
研究概览
简要总结
The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa & Type IIb Dyslipidaemia
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
- •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 creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
- •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)
结局指标
主要结局
Development of Proteinuria
时间窗: 2 weekly
次要结局
- Renal effects of rosuvastatin and simvastatin(2 weekly)
- Low density lipoproteins cholesterol levels(2 weekly)
- Safety: adverse events & abnormal laboratory markers(2 weekly)
研究者
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