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

March 30, 2012
August 21, 2014
March 2012
March 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01569867 on ClinicalTrials.gov Archive Site
Not Provided
  • lipid levels [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • clinical outcomes [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    cardiovascular events and adverse effects (liver or muscle toxicity)
Not Provided
Not Provided
 
Genetic Influence on Statin Pharmacokinetics
An Observational Study Investigating Genetic Influences on Statin Plasma Concentrations in Adults Taking Atorvastatin, Simvastatin, or Lovastatin

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Frozen plasma and frozen nuclear pellet

Non-Probability Sample

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

  • Hyperlipidemia
  • Hypercholesterolemia
  • Dyslipidemia
Not Provided
statin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
March 2022
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • taking atorvastatin, simvastatin, or lovastatin

Exclusion Criteria:

  • concomitant use of medications, supplements, OTCs known to interfere with statin metabolism
Both
18 Years and older
No
Contact: Joseph P Kitzmiller, MD PhD (614) 292 8438 joseph.kitzmiller@osumc.edu
United States
 
NCT01569867
K23-GM100372-01, K23GM100372
No
Joseph Kitzmiller, Ohio State University
Ohio State University
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University
Ohio State University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP