Genetic Influences on Statin Blood Concentrations in African Americans

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.

Completed

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Key information

Conditions

Hyperlipidemia Dyslipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Age less than 18 years

Treatment and study plan

Primary outcomes

24-hour area under the time-concentration curve of statin concentrations in plasma

Time frame: 2 years

Secondary outcomes

Incidence of statin-associated muscle symptoms (SAMS)

Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

National Institute of General Medical Sciences (NIGMS)
National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2022
Study completion: 2022
First posted: Apr 3, 2012
Registry last updated: Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed