A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

May 18, 2018 updated by: Cui Yimin
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients taking simvastatin therapy
  • Signed informed consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
wild genotype
Through next generation sequencing, distinguish wild genotype of simvastatin
Genetic: detection of genotype
detection of genotype by next generation sequencing
mutant genotype
Through next generation sequencing, distinguish mutant genotype of simvastatin
Genetic: detection of genotype
detection of genotype by next generation sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of hepatic impairment
Time Frame: At 2 years
At 2 years
Incidence of myopathy
Time Frame: At 2 years
At 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype detected by next generation sequencing
Time Frame: pre-dose of simvastatin(Baseline)
Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing.
pre-dose of simvastatin(Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cui Yimin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016[1237]

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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