Fenofibrate and Pharmacogenetic Impact in Dyslipidemia
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Purpose
click on markers to display additional informationThe 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.
status: recruiting conditions: Dyslipidemia interventions: fenofibrate ; fenofibrate phase: Phase 4 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 -
Further study details (as provided by University of Minnesota)
primary outcome measures:
- Triglyceride lowering response [ Time Frame: 4 weeks ]
secondary outcome measures:
- Pharmacokinetic parameters based on genotype [ Time Frame: 4 weeks ]
enrollment: 50
study start date: January 2008
study completion date: June 2010
Arms Assigned Interventions 1: Active Comparator
High drug metabolism genotype
Drug: fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
2: Active Comparator
Low drug metabolism genotype
Drug: fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
Detailed description
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.
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Eligibility
ages eligible for study: 18 Years to 75 Years genders eligible for study: Both Criteria
Inclusion Criteria:
- 18-75 year old
- Be willing to participate in the study and attend the scheduled clinic exams
- Consent to taking lipid lowering therapy for 4 weeks and if necessary discontinue lipid lowering agents for a period of 8 weeks
Exclusion Criteria:
- <18 years of age
- History of liver, kidney, pancreas, pancreatitis, gall bladder disease or malabsorption (Crohn's disease etc.)
- Use of insulin or currently taking warfarin
- Pregnant women or women of childbearing potential not using an acceptable form of contraception
- History of an allergy or hypersensitivity to fenofibrate
- Investigational drug use within 30 days of the study
- A disease that, in the opinion, of the PI, would put the subject at risk during the study
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Contacts and locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613613
Contacts
Robert J. Straka 612-624-5663 strak001@umn.edu Locations
United States , Minnesota - University of Minnesota
status: recruiting facility: Minneapolis, Minnesota, United States, 55455 contact: Robert J Straka 612-624-5663 strak001@umn.edu Principal Investigator: Robert J. Straka
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Sponsors and collaborators
University of Minnesota
Laval University
investigators: Robert J. Straka, Principal Investigator, University of Minnesota
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More information
first received: January 31, 2008 last updated: June 12, 2009 ClinicalTrials.gov Identifier: NCT00613613 health authority: United States: Institutional Review Board
Information obtained from ClinicalTrials.gov on September 25, 2009 Link to the current ClinicalTrials.gov record.
