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LXRA Gene Polymorphisms and Response to Fenofibrate

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Fenofibrate capsule daily for 4 weeks (Drug); Fenofibrate (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Issam Zineh, PharmD, Principal Investigator, Affiliation: University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics

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.

Clinical Details

Official title: LXRA Gene Polymorphisms and Response to Fenofibrate

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Log(ENA-Period 2 End/ENA Period 1 End)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: March 2008
Last updated: May 24, 2012

Page last updated: August 23, 2015

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