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Study of Trilipix Effects on Lipids and Arteries

This study has been terminated.
(Corporate sponsor withdrew funding and permission to continue.)
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01025492
First received: December 1, 2009
Last updated: July 27, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
 Drug: Trilipix (fenofibric acid)
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanisms of Atheroprotection by Fenofibric Acid (ABT 335) Added to a Statin in Subjects With Insulin Resistance (Hypertriglyceridemia and Low HDL-C)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • HDL composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fenofibric acid Drug: Trilipix (fenofibric acid)
135 mg po daily
Other Name: Trilipix
Placebo Comparator: Placebo Drug: placebo
one tablet po daily

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025492

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Abbott
  More Information

No publications provided

Responsible Party: Eliot A. Brinton, MD, University of Utah
ClinicalTrials.gov Identifier: NCT01025492     History of Changes
Other Study ID Numbers: 00030151
Study First Received: December 1, 2009
Last Updated: July 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
high density lipoprotein
arterial compliance
brachial artery flow-mediated dilatation

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Fenofibric acid
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents

ClinicalTrials.gov processed this record on May 19, 2013