Fenofibrate and Pharmacogenetic Impact in Dyslipidemia

Dyslipidemia Clinical Trial

— FPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613613
• Other study ID #: 0708M15441
• Secondary ID: AHA Grant #07558
• Status: Completed
• Start date: January 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
• fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Laval University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers	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.	24 hours