Fenofibrate and Pharmacogenetic Impact in Dyslipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

High drug metabolism genotype All receive fenofibrate

fenofibrate

Intervention Type DRUG

Fenofibrate 145mg tablets once daily for 4 weeks

2

Low drug metabolism genotype All receive fenofibrate

fenofibrate

Intervention Type DRUG

Fenofibrate 145mg tablets once daily for 4 weeks

Interventions

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fenofibrate

Fenofibrate 145mg tablets once daily for 4 weeks

Intervention Type DRUG

fenofibrate

Fenofibrate 145mg tablets once daily for 4 weeks

Intervention Type DRUG

Other Intervention Names

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TriCor® 145mg tablets TriCor® 145mg tablets

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes