NCT00120055已完成4 期
Association Between Systemic Exposure of Atorvastatin and Metabolites and Atorvastatin-induced Myotoxicity
University of Oslo School of Pharmacy0 个研究点开始时间: 2005年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 主要终点
- Statin toxicity
研究概览
简要总结
The aim of this study is to investigate whether the pharmacokinetics of atorvastatin and/or its metabolites is altered in patients with confirmed atorvastatin-induced myopathy compared to healthy controls.
详细描述
A 24 hour pharmacokinetic investigation of atorvastatin and metabolites will be performed in 15 patients with a history of atorvastatin -induced myotoxicity. The possible link to relevant mutations in SLCO1B1, CYP3A5 and MDR1 will be also be investigated
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •above 18 years
- •previous history of atorvastatin-associated myotoxicity
排除标准
- •current treatment with drugs or herbal remedies with known pharmacokinetic interaction potential with atorvastatin
- •previous CK levels above ten times the upper limit of normal range
- •pregnancy and persistent muscular complaints after a four week wash-out period of statin treatment
结局指标
主要结局
Statin toxicity
时间窗: 1 year
Rechallenge test of statin induce toxicity
次要结局
未报告次要终点
研究者
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