LXRA Gene Polymorphisms and Response to Fenofibrate

NCT00644592 | Terminated Results

• 1 other identifier: 302-2007
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Log(ENA-Period 2 End/ENA Period 1 End)

  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

  week 12 to week 4

Study Arms (2)

1-Fenofibrate then Placebo

ACTIVE COMPARATOR

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; Drug: Fenofibrate

2 Placebo then Fenofibrate

ACTIVE COMPARATOR

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; Drug: Fenofibrate

Interventions

Fenofibrate capsule daily for 4 weeks DRUG

Placebo capsule daily for 4 weeks

1-Fenofibrate then Placebo; 2 Placebo then Fenofibrate

Fenofibrate DRUG

160 mg/day orally for 4 weeks

1-Fenofibrate then Placebo; 2 Placebo then Fenofibrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• American College of Clinical Pharmacy: collaborator

Study Sites (1)

University of Florida College of Pharmacy, Center for Pharmacogenomics

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Fenofibrate

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Reginald F. Frye, PhD, Associate Professor
• Organization: University of Florida

fryerf@ufl.edu

3522735453

Study Officials

• Issam Zineh, PharmD

  University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 27, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 1, 2012
• Results First Posted: May 24, 2012

Record last verified: 2012-05

Locations

US (1)