A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

• Sponsor: Cui Yimin (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03261908
• Collaborator: (none)
• Enrollment: 2,200
• Location: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 548.9

Study Details

Study Description

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	Phase
Simvastatin Adverse Reaction; Pharmacogenomics; Accurate Medication	Genetic: detection of genotype

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2200 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
• Anticipated Study Start Date: Aug 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Incidence of hepatic impairment [At 2 years]

2. Incidence of myopathy [At 2 years]

Secondary Outcome Measures

1. Genotype detected by next generation sequencing [pre-dose of simvastatin(Baseline)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients taking simvastatin therapy

• Signed informed consent.

Exclusion Criteria:

• Patients not taking simvastatin therapy

• Intolerance or unwillingness to blood sample collection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034

Sponsors and Collaborators

• Cui Yimin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cui Yimin, Director of pharmacy，M.D & Ph.D, Peking University First Hospital
• ClinicalTrials.gov Identifier: NCT03261908
• Other Study ID Numbers: 2016[1237]
• First Posted: Aug 25, 2017
• Last Update Posted: May 22, 2018
• Last Verified: May 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions

Study Results

No Results Posted as of May 22, 2018