Fenofibrate and Pharmacogenetic Impact in Dyslipidemia
Information source: University of Minnesota
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: fenofibrate (Drug); fenofibrate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
Robert J. Straka, Principal Investigator, Affiliation: University of Minnesota
Overall contact:
Robert J. Straka, Phone: 612-624-5663, Email: strak001@umn.edu
Summary
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.
Clinical Details
Official title: The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response
Study design: Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Triglyceride lowering response
Secondary outcome: Pharmacokinetic parameters based on genotype
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): 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
Locations and Contacts
Robert J. Straka, Phone: 612-624-5663, Email: strak001@umn.edu
University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Robert J Straka, Phone: 612-624-5663, Email: strak001@umn.edu
Robert J. Straka, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: June 2010
Last updated: June 12, 2009
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