- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01023750
Predictors of Response to Fenofibrate (PreFar)
October 11, 2015 updated by: University of Alabama at Birmingham
Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35294
- UAB Kirklin Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Women who are seen in the UAB Diabetes and Endocrine Clinic or Cardiology Clinic
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in fasting triglyceride concentrations
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in lipids and markers of insulin resistance
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edmond K Kabagambe, DVM, PhD, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
November 30, 2009
First Submitted That Met QC Criteria
December 1, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Estimate)
October 14, 2015
Last Update Submitted That Met QC Criteria
October 11, 2015
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21DK084560 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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