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LXRA Gene Polymorphisms and Response to Fenofibrate

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ClinicalTrials.gov Identifier: NCT00644592
Recruitment Status : Terminated (supply issues with the formulation of fenofibrate that was used.)
First Posted : March 27, 2008
Results First Posted : May 24, 2012
Last Update Posted : June 1, 2012
Sponsor:
Collaborator:
American College of Clinical Pharmacy
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Fenofibrate capsule daily for 4 weeks Drug: Fenofibrate Not Applicable

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 terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: LXRA Gene Polymorphisms and Response to Fenofibrate
Study Start Date : March 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1-Fenofibrate then Placebo
4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo
Drug: Fenofibrate capsule daily for 4 weeks
Placebo capsule daily for 4 weeks
Drug: Fenofibrate
160 mg/day orally for 4 weeks
Active Comparator: 2 Placebo then Fenofibrate
4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
Drug: Fenofibrate capsule daily for 4 weeks
Placebo capsule daily for 4 weeks
Drug: Fenofibrate
160 mg/day orally for 4 weeks



Primary Outcome Measures :
  1. Log(ENA-Period 2 End/ENA Period 1 End) [ Time Frame: week 12 to week 4 ]

    Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.

    Natural logs used




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644592


Locations
United States, Florida
University of Florida College of Pharmacy, Center for Pharmacogenomics
Gainesville, Florida, United States, 32610
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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00644592     History of Changes
Other Study ID Numbers: 302-2007
First Posted: March 27, 2008    Key Record Dates
Results First Posted: May 24, 2012
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by University of Florida:
Healthy Volunteers

Additional relevant MeSH terms:
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents