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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This study has been withdrawn prior to enrollment.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
  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:


Further study details as provided by Joseph Kitzmiller, Ohio State University:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
nuclear pellet

Enrollment: 0
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569854


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
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

Responsible Party: Joseph Kitzmiller, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01569854     History of Changes
Other Study ID Numbers: OSU 2011H0261
K23GM100372 ( U.S. NIH Grant/Contract )
First Submitted: March 30, 2012
First Posted: April 3, 2012
Last Update Posted: September 27, 2016
Last Verified: September 2016

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