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Genetic Influence on Statin Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01569867
Recruitment Status : Recruiting
First Posted : April 3, 2012
Last Update Posted : September 27, 2016
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University

Brief Summary:
This study intends to investigate genetic influences on how individuals process statins.

Condition or disease
Hyperlipidemia Hypercholesterolemia Dyslipidemia

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Investigating Genetic Influences on Statin Plasma Concentrations in Adults Taking Atorvastatin, Simvastatin, or Lovastatin
Study Start Date : March 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. statin concentration in plasma [ Time Frame: 2 years ]
    A trough level will be measured in all participants; some participants will have additional measurements if their statin dose is changed, and individuals with certain genetic status may provide additional samples to construct a full PK profile.

Biospecimen Retention:   Samples With DNA
Frozen plasma and frozen nuclear pellet

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).

Inclusion Criteria:

  • taking atorvastatin, simvastatin, or lovastatin

Exclusion Criteria:

  • concomitant use of medications, supplements, OTCs known to interfere with statin metabolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01569867

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Contact: Joseph P Kitzmiller, MD PhD (614) 292 8438

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United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Joseph P Kitzmiller, MD PhD         
Sub-Investigator: Wolfgang Sadee, Dr rer nat         
Sub-Investigator: Mitch Phelps, PhD         
Sub-Investigator: Rebecca Jackson, MD         
Sponsors and Collaborators
Ohio State University
National Institute of General Medical Sciences (NIGMS)
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Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University

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Responsible Party: Joseph Kitzmiller, Assistant Professor, Ohio State University Identifier: NCT01569867     History of Changes
Other Study ID Numbers: OSU 2011H0402
K23GM100372 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents