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Completed

NCT Number: NCT00613613

Fenofibrate and Pharmacogenetic Impact in Dyslipidemia

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. The 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

The investigators 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate

Drug

Fenofibrate 145mg tablets once daily for 4 weeks

Other names: TriCor® 145mg tablets

Primary outcomes

  1. Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers

    Time frame: 24 hours

    We measured area under the curve (AUC) in mcg*hr/mL (from time 0 to 24 hrs) at steady state for those of two specific genotypes for our UGT2B7 SNP following steady-state dosing of fenofibrate.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Laval University

Registry information

Official study title

The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response

Acronym: FPI

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2008
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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