NCT01569867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

9.8 years

First QC Date

March 30, 2012

Last Update Submit

October 12, 2022

Conditions

HyperlipidemiaHypercholesterolemiaDyslipidemia

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (1)

  • Incidence of statin-associated muscle symptoms (SAMS)

    10 years

Study Arms (1)

statin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).

You may qualify if:

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

You may not qualify if:

  • Age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related 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.

    PMID: 25612772BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Frozen plasma and frozen nuclear pellet

MeSH Terms

Conditions

HyperlipidemiasHypercholesterolemiaDyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Joseph P Kitzmiller, MD PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2012

First Posted

April 3, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2022

Study Completion

April 20, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

US(1)