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Genetic Influence on Statin Pharmacodynamics

This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University
ClinicalTrials.gov Identifier:
NCT01569854
First received: March 30, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)


Condition
Hyperlipidemia
Hypercholesterolemia
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Investigating Genetic Influences on Clinical Outcomes and Change in Carotid Intimal Thickness in Adults Taking Atorvastatin, Simvastatin, or Lovastatin

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • carotid intimal media thickness (CIMT) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    CIMT measurements will be performed at baseline (within 3 months of starting statin) and at 6, 12, 18, and 24 months. Change in CIMT is considered a surogate measure of atherosclerotic progression.


Biospecimen Retention:   Samples With DNA

nuclear pellet


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2014 (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:

  • recently (within past 3 months) started taking atorvastatin, lovastatin, or simvastatin

Exclusion Criteria:

  • concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569854

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

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Joseph P Kitzmiller, MD PhD     614-292-8438     joseph.kitzmiller@osumc.edu    
Principal Investigator: Joseph P Kitzmiller, MD PhD            
Sub-Investigator: Bhagwan Satiani, MD            
Sub-Investigator: Michael Go, MD            
Sub-Investigator: Rebecca Jackson, MD            
Sponsors and Collaborators
Ohio State University
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University
  More Information

No publications provided

Responsible Party: Joseph Kitzmiller, Research Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01569854     History of Changes
Other Study ID Numbers: K23-GM1000372-02, K23GM100372
Study First Received: March 30, 2012
Last Updated: May 16, 2013
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 May 23, 2013