Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Genetic Influence on Statin Pharmacodynamics

This study has been withdrawn prior to enrollment.
(Insufficient recruitment)
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: September 26, 2016
Last verified: September 2016
  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 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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: 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 
Study First Received: March 30, 2012
Last Updated: September 26, 2016
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 December 09, 2016