NCT00199745已完成4 期
Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2005年10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
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
研究概览
简要总结
The primary objective of the study is to investigate whether differences in atorvastatin metabolite ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.
详细描述
The primary objective of the study is to investigate whether differences in atorvastatin metabolites ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Suspected atorvastatin induced muscle adverse events
- •Signed informed consent
- •18 years of age or older
- •Able to donate blood samples
- •Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)
排除标准
- 未提供
结局指标
主要结局
To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
次要结局
- Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
研究者
研究点 (2)
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