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Sponsors and Collaborators: |
University of Minnesota Laval University |
Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00613613 |
The purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and FDA (Food and Drug Administration) approved medication for lowering triglycerides and cholesterol. Our hypothesis: The pharmacogenetics of genes which affect drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the body) influences how a person responds to the lipid lowering medication- fenofibrate.
Condition | Intervention | Phase |
Dyslipidemia |
Drug: fenofibrate |
Phase IV |
Drug Information available for: | Procetofen Lipids |
Study Type: | Interventional |
Study Design: | Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
High drug metabolism genotype
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Drug: fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
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2: Active Comparator
Low drug metabolism genotype
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Drug: fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
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We seek to screen over 200 subjects for select candidate genes to serve as a source of subjects which may participate in a genotype guided investigation as to the predictability of response based on genotype. Response endpoints relate to lipid parameters and other variables of interest to cardiovascular endpoints. Subjects with genotypes of interest would then be enrolled into a short term clinical trial evaluating their response to fenofibrate based on their genetic profile ascertained from the screening phase. We hope to evaluate ~50 subjects in the second phase.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert J. Straka | 612-624-5663 | strak001@umn.edu |
Contact: Azher Arafah | 612-624-9683 | arafa002@umn.edu |
United States, Minnesota | |||||
University of Minnesota | Recruiting | ||||
Minneapolis, Minnesota, United States, 55455 | |||||
Contact: Robert J Straka 612-624-5663 strak001@umn.edu | |||||
Principal Investigator: Robert J. Straka |
University of Minnesota |
Laval University |
Principal Investigator: | Robert J. Straka | University of Minnesota |
Responsible Party: | University of Minnesota ( Robert Straka, Associate Professor ) |
Study ID Numbers: | 0708M15441, AHA Grant #0755839Z |
First Received: | January 31, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00613613 |
Health Authority: | United States: Institutional Review Board |
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