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Genetic Influence on Statin Pharmacodynamics
This study has been withdrawn prior to enrollment.
(Insufficient recruitment)
Sponsor:
Ohio State University
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
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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) |
| Groups/Cohorts |
|---|
| statin |
Eligibility| 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
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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
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | March 30, 2012 |
| Last Updated: | September 26, 2016 |
Additional relevant MeSH terms:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 22, 2017