Genetic Influence on Statin Pharmacokinetics

This study is currently recruiting participants.
Verified February 2014 by Ohio State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University
ClinicalTrials.gov Identifier:
NCT01569867
First received: March 30, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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


Condition
Hyperlipidemia
Hypercholesterolemia
Dyslipidemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • statin concentration in plasma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 800
Study Start Date: March 2012
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).

Criteria

Inclusion Criteria:

  • taking atorvastatin, simvastatin, or lovastatin

Exclusion Criteria:

  • concomitant use of medications, supplements, OTCs known to interfere with statin metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569867

Contacts
Contact: Joseph P Kitzmiller, MD PhD (614) 292 8438 joseph.kitzmiller@osumc.edu

Locations
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
Investigators
Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University
  More Information

No publications provided

Responsible Party: Joseph Kitzmiller, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01569867     History of Changes
Other Study ID Numbers: K23-GM100372-01, K23GM100372
Study First Received: March 30, 2012
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 23, 2014