LXRA Gene Polymorphisms and Response to Fenofibrate

This study is ongoing, but not recruiting participants.

First Received: March 21, 2008 Last Updated: November 17, 2009 History of Changes

Sponsor:	University of Florida
Collaborator:	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

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

Resource links provided by NLM:

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
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

Locations

United States, Florida
University of Florida College of Pharmacy, Center for Pharmacogenomics
Gainesville, Florida, United States, 32610
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 College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics ( Issam Zineh, PharmD )
Study ID Numbers:	302-2007
Study First Received:	March 21, 2008
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00644592 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Healthy Volunteers

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Procetofen
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009