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Genetic Influence on Statin Pharmacodynamics

This study has been withdrawn prior to enrollment.
(Insufficient recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01569854
First Posted: April 3, 2012
Last Update Posted: September 27, 2016
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. Read our disclaimer for details.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University
March 30, 2012
April 3, 2012
September 27, 2016
March 2012
March 2016   (Final data collection date for primary outcome measure)
carotid intimal media thickness (CIMT) [ Time Frame: 2 years ]
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.
Same as current
Complete list of historical versions of study NCT01569854 on ClinicalTrials.gov Archive Site
Not Provided
clinical outcomes [ Time Frame: 10 years ]
cardiovascular events; muscle or liver toxicity
Not Provided
Not Provided
 
Genetic Influence on Statin Pharmacodynamics
An Observational Study Investigating Genetic Influences on Clinical Outcomes and Change in Carotid Intimal Thickness in Adults Taking Atorvastatin, Simvastatin, or Lovastatin
The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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.
 
Withdrawn
0
March 2022
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01569854
OSU 2011H0261
K23GM100372 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
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
September 2016