LXRA Gene Polymorphisms and Response to Fenofibrate

This study is currently recruiting participants.

Verified by University of Florida, March 2008

First Received: March 21, 2008 Last Updated: March 25, 2008 History of Changes

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

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

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

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:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00644592 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Healthy Volunteers

Study placed in the following topic categories:

Antimetabolites
Antilipemic Agents
Healthy
Procetofen

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Procetofen
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009