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LXRA Gene Polymorphisms and Response to Fenofibrate
This study has been completed.
Study NCT00644592   Information provided by University of Florida
First Received: March 21, 2008   Last Updated: December 1, 2009   History of Changes

March 21, 2008
December 1, 2009
March 2008
August 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
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Pharmacodynamics Study
Intervention Model:  Crossover Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Basic Science
Healthy
  • Drug: Fenofibrate
    160mg by mouth daily for 4 weeks
  • Drug: Placebo
    Placebo capsule by mouth daily for 4 weeks
  • 1: Active Comparator
    Intervention: Drug: Fenofibrate
  • 2: Placebo Comparator
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
August 2009
August 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
December 2009

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