ClinicalTrials.gov
ClinicalTrials.gov Menu

Fenofibrate and Pharmacogenetic Impact in Dyslipidemia (FPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00613613
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Laval University
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: fenofibrate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response
Study Start Date : January 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
High drug metabolism genotype All receive fenofibrate
Drug: fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
Other Name: TriCor® 145mg tablets
Active Comparator: 2
Low drug metabolism genotype All receive fenofibrate
Drug: fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
Other Name: TriCor® 145mg tablets



Primary Outcome Measures :
  1. Triglyceride lowering response [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters based on genotype [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: University of Minnesota )
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents