Predictors of Response to Fenofibrate
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertriglyceridemia; Insulin Resistance
Intervention: Fenofibrate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s):
Edmond K Kabagambe, DVM, PhD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Overall contact:
Edmond K Kabagambe, DVM, PhD, Phone: 205-934-2950, Email: edmondk@uab.edu
Summary
Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of
patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and
LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there
are no screening tests to identify poor responders. Genetic and environmental factors may
explain the high variability in response. Although exploratory in nature, this study is of
clinical and public health importance because prediction of drug response among those with
hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large
($90 to $130/patient/month); targeting the responsive patients at the outset will help
improve treatment outcomes at a lower cost. If successful, the investigators will propose to
conduct a large, randomized trial on the effect of pre-prescription genotyping on
fenofibrate response.
Clinical Details
Official title: Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in fasting triglyceride concentrations
Secondary outcome: Changes in lipids and markers of insulin resistance
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 19 years old or over dyslipidemic patients designated to receive fenofibrate by their
attending physician.
- All patients will be seen at the UAB Diabetes and Endocrine Clinic or Cardiology
Clinic.
- Women who are unable to have children because of surgery or other medical reason or
are using an effective form of birth control before the study begins and agree to
continue to use an effective form of birth control for 6 months after taking the
study drug.
Exclusion Criteria:
- Under 19 and/or not a Dyslipidemic patient or dyslipidemic but with a medical
condition (e. g., liver or kidney disease) that warrants contraindication of
fenofibrate.
- Women who are pregnant, nursing and women who, unless they are unable to have
children because of surgery or other medical reason, have not been using an effective
form of birth control before the study begins and/or are unwilling to use an
effective form of birth control for 6 months after taking the study drug will be
excluded from the study.
Locations and Contacts
Edmond K Kabagambe, DVM, PhD, Phone: 205-934-2950, Email: edmondk@uab.edu
UAB Kirklin Clinic, Birmingham, Alabama 35294, United States; Recruiting
Additional Information
Starting date: January 2010
Last updated: March 21, 2012
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