NCT03261908

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

August 23, 2017

Last Update Submit

May 18, 2018

Conditions

Simvastatin Adverse ReactionPharmacogenomicsAccurate Medication

Outcome Measures

Primary Outcomes (2)

  • Incidence of hepatic impairment

    At 2 years

  • Incidence of myopathy

    At 2 years

Secondary Outcomes (1)

  • Genotype detected by next generation sequencing

    pre-dose of simvastatin(Baseline)

Study Arms (2)

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

detection of genotypeGENETIC

detection of genotype by next generation sequencing

mutant genotypewild genotype

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients taking simvastatin therapy
  • Signed informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Central Study Contacts

Qian Xiang, Ph.D

CONTACT

+86 010 66110802xiangqz@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of pharmacy，M.D & Ph.D

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

August 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

CN(1)