Genetic Influences on Statin Blood Concentrations in African Americans

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01569867

Enrollment

501

Registered

2012-04-03

Start date

2012-03-31

Completion date

2022-04-20

Last updated

2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypercholesterolemia, Hyperlipidemia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Age less than 18 years

Design outcomes

Primary

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

Secondary

Measure	Time frame
Incidence of statin-associated muscle symptoms (SAMS)	10 years

Countries

United States

Outcome results