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临床试验/NCT03261908
NCT03261908Unknown不适用

A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

Cui Yimin1 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2018年8月最近更新:
适应症

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

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

发起方
Cui Yimin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cui Yimin

Director of pharmacy,M.D & Ph.D

Peking University First Hospital

研究点 (1)

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