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LXRA Gene Polymorphisms and Response to Fenofibrate
This study is ongoing, but not recruiting participants.
Study NCT00644592   Information provided by University of Florida
First Received: March 21, 2008   Last Updated: November 17, 2009   History of Changes

March 21, 2008
November 17, 2009
March 2008
December 2009   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00644592 on ClinicalTrials.gov Archive Site
 
 
 
LXRA Gene Polymorphisms and Response to Fenofibrate
LXRA Gene Polymorphisms and Response to Fenofibrate

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.

 
 
Interventional
Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Healthy
  • Drug: Fenofibrate
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00644592
Issam Zineh, PharmD, University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
302-2007
University of Florida
American College of Clinical Pharmacy
Principal Investigator: Issam Zineh, PharmD University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
University of Florida
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP