A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Incidence of hepatic impairment
研究概览
简要总结
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. In this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to Chinese population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients taking simvastatin therapy
- •Signed informed consent.
排除标准
- •Patients not taking simvastatin therapy
- •Intolerance or unwillingness to blood sample collection.
结局指标
主要结局
Incidence of hepatic impairment
时间窗: At 2 years
Incidence of myopathy
时间窗: At 2 years
次要结局
- Genotype detected by next generation sequencing(pre-dose of simvastatin(Baseline))
研究者
Cui Yimin
Director of pharmacy,M.D & Ph.D
Peking University First Hospital
