CClinicalTrials.gg
Status unknownNCT03261908Updated May 22, 2018

A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

An observational study in Simvastatin Adverse Reaction, Pharmacogenomics and Accurate Medication, sponsored by Cui Yimin. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-22.

Sponsored by Cui Yimin · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,200
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Simvastatin Adverse Reaction
  • Pharmacogenomics
  • Accurate Medication
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chinese Patients:In accordance with anti-hyperlipemia indications of simvastatin

Inclusion criteria

  • Patients taking simvastatin therapy
  • Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients not taking simvastatin therapy
  • Intolerance or unwillingness to blood sample collection.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • wild genotype

    Through next generation sequencing, distinguish wild genotype of simvastatin

    Genetic: detection of genotype

  • mutant genotype

    Through next generation sequencing, distinguish mutant genotype of simvastatin

    Genetic: detection of genotype

Interventions

  • Geneticdetection of genotype

    detection of genotype by next generation sequencing

05

What researchers measure

Primary outcomes

  1. Incidence of hepatic impairment

    Time frame: At 2 years

  2. Incidence of myopathy

    Time frame: At 2 years

Secondary outcomes

  1. Genotype detected by next generation sequencing

    Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing.

    Time frame: pre-dose of simvastatin(Baseline)

06

Study locations

1 of 1 sites recruiting
  • Peking University First Hospital
    Beijing, Beijing 100034, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03261908
Lead sponsor
Cui Yimin
Responsible party
Cui Yimin (Director of pharmacy,M.D & Ph.D, Peking University First Hospital) — Sponsor-investigator
First posted
Aug 25, 2017
Start date
Aug 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
May 22, 2018

Study contacts

Qian Xiang, Ph.D
Contact
xiangqz@126.com
+86 010 66110802

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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