LXRA Gene Polymorphisms and Response to Fenofibrate
Information source: University of Florida
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Fenofibrate (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Florida Official(s) and/or principal investigator(s):
Issam Zineh, PharmD, Principal Investigator, Affiliation: University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
Overall contact:
Elvin T Price, PharmD, Phone: 352-273-6446, Email: eprice@ufl.edu
Summary
This is a research study of how a cholesterol medication known as fenofibrate works
differently in people with different genetic backgrounds. "Genetics" refers to certain
things that are passed to a person by their parents, such as eye color or hair color.
Genetic differences lead to people having different eye and hair color. There are also
genetic differences in a protein called liver X receptor-alpha (LXRA), which may be
important in predicting the response to fenofibrate.
Clinical Details
Official title: LXRA Gene Polymorphisms and Response to Fenofibrate
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: Lipids (Triglycerides, LDL, HDL)CRP
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below
54 mg/dl for women)
- Must be able to swallow tablets
Exclusion Criteria:
- Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic
aneurysm, diabetes, or Framingham risk score above 20%
- Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse,
history of unexplained muscle pain
- Current treatment with lipid lowering therapy, estrogens, androgens, progestins,
thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled),
antihistamines, or chronic anti-inflammatory drugs
- Current treatment with the following the interacting drugs: ursodeoxycholic acid,
ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or
cyclosporine
Locations and Contacts
Elvin T Price, PharmD, Phone: 352-273-6446, Email: eprice@ufl.edu
University of Florida College of Pharmacy, Center for Pharmacogenomics, Gainesville, Florida 32610, United States; Recruiting
Elvin T Price, PharmD, Phone: 352-273-6446, Email: eprice@ufl.edu
Issam Zineh, PharmD, Phone: 352-273-6184, Email: zineh@cop.ufl.edu
Additional Information
Starting date: March 2008
Ending date: December 2009
Last updated: March 25, 2008
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