LXRA Gene Polymorphisms and Response to Fenofibrate

This study has been completed.

First Received on March 21, 2008. Last Updated on September 16, 2011 History of Changes

Sponsor:	University of Florida
Collaborator:	American College of Clinical Pharmacy
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	LXRA Gene Polymorphisms and Response to Fenofibrate

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

Drug Information available for: Procetofen

U.S. FDA Resources

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
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

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

More Information

No publications provided

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00644592 History of Changes
Other Study ID Numbers:	302-2007
Study First Received:	March 21, 2008
Last Updated:	September 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Healthy Volunteers

Additional relevant MeSH terms:

Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012