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NCT01569867 Clinical Trial

Genetic Influences on Statin Blood Concentrations in African Americans

Hypercholesterolemia Clinical Trial

Official title:
An Observational Study Investigating Genetic Influences on Statin Plasma Concentrations in Adult African American Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01569867
Other study ID # OSU 2011H0402
Secondary ID K23GM100372R01MD
Status Completed
Phase
First received
Last updated
Start date March 2012
Est. completion date April 20, 2022

Study information
Verified date October 2022
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study intends to determine the effects of genetic polymorphisms on statin response and daily systemic exposure (24-hour area under the time-concentration curve) of statins in African-American patients.

Recruitment information / eligibility
Status Completed
Enrollment 501
Est. completion date April 20, 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - African-American patients taking a statin metabolized by CYP3A (e.g., atorvastatin, simvastatin, or lovastatin) Exclusion Criteria: - Age less than 18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Ohio State University Medical Center Columbus Ohio

Sponsors (3)
Lead Sponsor Collaborator
Ohio State University National Institute of General Medical Sciences (NIGMS), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wang J, Luzum JA, Phelps MA, Kitzmiller JP. Liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of simvastatin, lovastatin, atorvastatin, and their major metabolites in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Mar 1;983-984:18-25. doi: 10.1016/j.jchromb.2014.12.029. Epub 2015 Jan 13. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 24-hour area under the time-concentration curve of statin concentrations in plasma 2 years
Secondary Incidence of statin-associated muscle symptoms (SAMS) 10 years
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