Study of Trilipix Effects on Lipids and Arteries
Information source: University of Utah
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia
Intervention: Trilipix (fenofibric acid) (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Utah Overall contact:
Eliot Brinton, MD, Phone: 801-581-3888, Ext: x 274, Email: eliot.brinton@utah.edu
Summary
The investigators will study the effects of the addition of Trilipix (fenofibric acid)
versus placebo to ongoing statin treatment on high density lipoprotein (HDL) composition and
arterial function.
Clinical Details
Official title: Mechanisms of Atheroprotection by Fenofibric Acid (ABT 335) Added to a Statin in Subjects With Insulin Resistance (Hypertriglyceridemia and Low HDL-C)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: HDL composition
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- TG 150-500 mg/dL
- HDL-C < 45 mg/dL in men, < 55 in women
- LDL-C < 130 mg/dL
- stable statin dose x 8 weeks
Exclusion Criteria:
- Prior use of a fibrate > 4 weeks ever (minimum 12 months off fibrate)
- Intolerance to medications to be used in study (fenofibric acid, albuterol,
nitroglycerin)
- Niacin or thiazolidinedione within the prior 12 months, or anticipated need to add
either during 6-month study period
- Diabetes Mellitus if either (1) diagnosed less than 3 months ago, (2) treated with
insulin, or (3) with an A1c >8%
- Anticipated need to change treatment regimen of statin (or other lipid agent) or
glycemic treatment during 6-month study period
- Uncontrolled hypertension (BP > 140/90), or changes in BP meds within prior 4 weeks,
or anticipated need to change BP meds during 6-month study period
- Documented CVD event (heart attack, stroke, or hospitalization for unstable angina or
revascularization procedure) in the past 6 months
- Use of warfarin (potential to interact adversely with fibrate therapy)
- Uncontrolled thyroid disease (TSH outside of normal range)
- Renal insufficiency (calculated GFR <50)
- Hepatic disease (ALT > 1. 5x ULN, diagnosis of hepatitis, cirrhosis)
- Active cholecystitis/cholelithiasis
- Active cancer (except basal cell or squamous cell skin cancer)
- Pregnancy, plan/desire to become pregnant, breast feeding
- Inability or unwillingness to provide informed consent
Locations and Contacts
Eliot Brinton, MD, Phone: 801-581-3888, Ext: x 274, Email: eliot.brinton@utah.edu
University of Utah, Salt Lake City, Utah 84108, United States; Recruiting
Eliot A Brinton, MD, Principal Investigator
Additional Information
Starting date: November 2009
Last updated: December 2, 2009
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