Status:
TERMINATED
LXRA Gene Polymorphisms and Response to Fenofibrate
Lead Sponsor:
University of Florida
Collaborating Sponsors:
American College of Clinical Pharmacy
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00644592
Start Date
March 1 2008
End Date
August 1 2009
Last Update
June 1 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Florida College of Pharmacy, Center for Pharmacogenomics
Gainesville, Florida, United States, 32610