Genetic Influence on Statin Pharmacokinetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 21, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014