Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261908
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

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.

Condition or disease Intervention/treatment
Simvastatin Adverse Reaction Pharmacogenomics Accurate Medication Genetic: detection of genotype

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Simvastatin

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




Primary Outcome Measures :
  1. Incidence of hepatic impairment [ Time Frame: At 2 years ]
  2. Incidence of myopathy [ Time Frame: At 2 years ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese Patients:In accordance with anti-hyperlipemia indications of simvastatin
Criteria

Inclusion Criteria:

  • Patients taking simvastatin therapy
  • Signed informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261908


Contacts
Layout table for location contacts
Contact: Qian Xiang, Ph.D +86 010 66110802 xiangqz@126.com

Locations
Layout table for location information
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Qian Xiang, Ph.D    +86 010 66110802    xiangqz@126.com   
Sponsors and Collaborators
Cui Yimin

Layout table for additonal information
Responsible Party: Cui Yimin, Director of pharmacy,M.D & Ph.D, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03261908     History of Changes
Other Study ID Numbers: 2016[1237]
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors