A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

NCT ID: NCT03261908

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Simvastatin Adverse Reaction Pharmacogenomics Accurate Medication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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wild genotype

Through next generation sequencing, distinguish wild genotype of simvastatin

detection of genotype

Intervention Type GENETIC

detection of genotype by next generation sequencing

mutant genotype

Through next generation sequencing, distinguish mutant genotype of simvastatin

detection of genotype

Intervention Type GENETIC

detection of genotype by next generation sequencing

Interventions

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detection of genotype

detection of genotype by next generation sequencing

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Patients taking simvastatin therapy
* Signed informed consent.

Exclusion Criteria

* Patients not taking simvastatin therapy
* Intolerance or unwillingness to blood sample collection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cui Yimin

OTHER

Sponsor Role lead

Responsible Party

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Cui Yimin

Director of pharmacy,M.D & Ph.D

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qian Xiang, Ph.D

Role: CONTACT

+86 010 66110802

Facility Contacts

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Qian Xiang, Ph.D

Role: primary

+86 010 66110802

Other Identifiers

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2016[1237]

Identifier Type: -

Identifier Source: org_study_id

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