Fenofibrate and Pharmacogenetic Impact in Dyslipidemia - Full Text View

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Collaborator:	Laval University
Information provided by (Responsible Party):	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00613613

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

Drug Information available for: Procetofen

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Triglyceride lowering response [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic parameters based on genotype [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 High drug metabolism genotype	Drug: fenofibrate Fenofibrate 145mg tablets once daily for 4 weeks Other Name: TriCor® 145mg tablets
Active Comparator: 2 Low drug metabolism genotype	Drug: fenofibrate Fenofibrate 145mg tablets once daily for 4 weeks Other Name: TriCor® 145mg tablets

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613613

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Laval University

Investigators

Principal Investigator:

Robert J. Straka

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00613613 History of Changes
Other Study ID Numbers:	0708M15441, AHA Grant #0755839Z
Study First Received:	January 31, 2008
Last Updated:	December 13, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2012