A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

Pharmacogenomics Clinical Trial

Official title:

A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261908
• Other study ID #: 2016[1237]
• Status: Recruiting
• Start date: August 2018
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Peking University First Hospital
• Contact: Qian Xiang, Ph.D
• Phone: +86 010 66110802
• Email: xiangqz[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients taking simvastatin therapy

• Signed informed consent.

Exclusion Criteria:

• Patients not taking simvastatin therapy

• Intolerance or unwillingness to blood sample collection.

Related Conditions & MeSH terms

• Accurate Medication
• Drug-Related Side Effects and Adverse Reactions
• Pharmacogenomics
• Simvastatin Adverse Reaction

Intervention

Genetic:
• detection of genotype
detection of genotype by next generation sequencing

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cui Yimin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hepatic impairment		At 2 years
Primary	Incidence of myopathy		At 2 years
Secondary	Genotype detected by next generation sequencing	Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing.	pre-dose of simvastatin(Baseline)