Genetic Influences on Statin Blood Concentrations in African Americans

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemia; Dyslipidemia

• Registration Number: NCT01569867
• Lead Sponsor: Ohio State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Primary Completion: 2022-01
• Study Completion: 2022-04-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

• African-American patients taking a statin metabolized by CYP3A (e.g., atorvastatin, simvastatin, or lovastatin)

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Exclusion Criteria

• Age less than 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour area under the time-concentration curve of statin concentrations in plasma	2 years

Secondary Outcome Measures

Name	Time	Method
Incidence of statin-associated muscle symptoms (SAMS)	10 years

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States