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Predictors of Response to Fenofibrate (PreFar)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023750
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Insulin Resistance Drug: Fenofibrate Phase 4

Study Design

Study Type : Observational
Actual Enrollment : 39 participants
Time Perspective: Prospective
Official Title: Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy
Study Start Date : January 2010
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Fenofibrate
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Fenofibrate Drug: Fenofibrate
Participants will give a baseline blood sample and begin the 4 week course of fenofibrate. Patients will be given a 33-day dose of 145 mg of fenofibrate to be taken by mouth once a day. All doses of fenofibrate will be purchased in one batch, prepared at the pharmacy under supervision. A study nurse will collect each patient's 33-day dose of fenofibrate from the pharmacy and dispense to the study participants in the clinics. Patients will be given instructions on how to take the medication and given a 24-hr phone number to call in case of questions or need for additional care. Each patient will receive a phone call at least 2 times during the course of the trial to monitor the progress. Our co-investigators, who are also physicians will be available in case a study participant needs additional care. If not available, study participants will be able to reach the cardiologist or endocrinologist on call through an additional phone number we will provide.
Other Names:
  • Brand Name: TRICOR
  • NDC# 00074-6123-90

Outcome Measures

Primary Outcome Measures :
  1. Change in fasting triglyceride concentrations [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Changes in lipids and markers of insulin resistance [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who are seen in the UAB Diabetes and Endocrine Clinic or Cardiology Clinic

Inclusion Criteria:

  • 19 years old or over dyslipidemic patients designated to receive fenofibrate by their attending physician.
  • All patients will be seen at the UAB Diabetes and Endocrine Clinic or Cardiology Clinic.
  • Women who are unable to have children because of surgery or other medical reason or are using an effective form of birth control before the study begins and agree to continue to use an effective form of birth control for 6 months after taking the study drug.

Exclusion Criteria:

  • Under 19 and/or not a Dyslipidemic patient or dyslipidemic but with a medical condition (e.g., liver or kidney disease) that warrants contraindication of fenofibrate.
  • Women who are pregnant, nursing and women who, unless they are unable to have children because of surgery or other medical reason, have not been using an effective form of birth control before the study begins and/or are unwilling to use an effective form of birth control for 6 months after taking the study drug will be excluded from the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023750

United States, Alabama
UAB Kirklin Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Tufts University
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Edmond K Kabagambe, DVM, PhD University of Alabama at Birmingham
More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01023750     History of Changes
Other Study ID Numbers: R21DK084560 ( U.S. NIH Grant/Contract )
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: November 2013

Keywords provided by University of Alabama at Birmingham:
Insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents