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LXRA Gene Polymorphisms and Response to Fenofibrate

This study is currently recruiting participants.
Verified by University of Florida, March 2008

Sponsors and Collaborators: University of Florida
American College of Clinical Pharmacy
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00644592
  Purpose

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.


Condition Intervention
Healthy
Drug: Fenofibrate
Drug: Placebo

ChemIDplus related topics:   Procetofen   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:   LXRA Gene Polymorphisms and Response to Fenofibrate

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   60
Study Start Date:   March 2008
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator Drug: Fenofibrate
160mg by mouth daily for 4 weeks
2: Placebo Comparator Drug: Placebo
Placebo capsule by mouth daily for 4 weeks

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644592

Contacts
Contact: Elvin T Price, PharmD     352-273-6446     eprice@ufl.edu    
Contact: Issam Zineh, PharmD     352-273-6184     zineh@cop.ufl.edu    

Locations
United States, Florida
University of Florida College of Pharmacy, Center for Pharmacogenomics     Recruiting
      Gainesville, Florida, United States, 32610
      Contact: Elvin T Price, PharmD     352-273-6446     eprice@ufl.edu    
      Contact: Issam Zineh, PharmD     352-273-6184     zineh@cop.ufl.edu    

Sponsors and Collaborators
University of Florida
American College of Clinical Pharmacy

Investigators
Principal Investigator:     Issam Zineh, PharmD     University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics    
  More Information


Responsible Party:   University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics ( Issam Zineh, PharmD )
Study ID Numbers:   302-2007
First Received:   March 21, 2008
Last Updated:   March 25, 2008
ClinicalTrials.gov Identifier:   NCT00644592
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Florida:
Healthy Volunteers  

Study placed in the following topic categories:
Healthy
Procetofen

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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