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LXRA Gene Polymorphisms and Response to Fenofibrate

This study is currently recruiting participants.
Study NCT00644592.   Last updated on March 25, 2008.   Information provided by University of Florida

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Descriptive Information Fields
Brief Title  LXRA Gene Polymorphisms and Response to Fenofibrate
Official Title  LXRA Gene Polymorphisms and Response to Fenofibrate
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 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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary Outcome Measure  Lipids (Triglycerides, LDL, HDL) [ Time Frame: Before and after 4 weeks of both fenofibrate and placebo ] [ Designated as safety issue: No ]
CRP [ Time Frame: Before and after 4 weeks of both fenofibrate and placebo ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Healthy
Intervention  Drug: Fenofibrate
Drug: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  60
Start Date  March 2008
Completion Date December 2009
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Elvin T Price, PharmD     352-273-6446     eprice@ufl.edu    
Contact: Issam Zineh, PharmD     352-273-6184     zineh@cop.ufl.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00644592
Organization ID 302-2007
Secondary IDs ††
Study Sponsor  University of Florida
Collaborators †† American College of Clinical Pharmacy
Investigators 
Principal Investigator:     Issam Zineh, PharmD     University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics    
Information Provided By University of Florida
Verification Date March 2008
First Received Date  March 21, 2008
Last Updated Date March 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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