Study of Trilipix Effects on Lipids and Arteries

NCT01025492 | Terminated Phase 4 Results

• 1 other identifier: 00030151
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Fibrates reduce atherosclerosis and cardiovascular disease events. A major mechanism of this benefit appears to be their ability to raise plasma high density lipoprotein cholesterol (HDL-C), especially in patients with high triglyceride levels. This study will investigate the effects of the addition of Trilipix (fenofibric acid) versus placebo to ongoing statin treatment on high density lipoprotein (HDL) composition and arterial function in subjects with insulin resistance.

Conditions

Dyslipidemia

Keywords

high density lipoprotein; arterial compliance; brachial artery flow-mediated dilatation

Outcome Measures

Primary Outcomes (1)

• Apolipoprotein A-I Serum Concentration

  Comparison of apolipoprotein A-I concentrations after 12 weeks of treatment with either Trilipix or placebo

  12 weeks

Study Arms (2)

Trilipix

ACTIVE COMPARATOR

Trilipix (fenofibric acid) 135 mg tablet orally, once daily for 12 weeks

Drug: Trilipix

Placebo

PLACEBO COMPARATOR

Matching placebo tablet orally, once daily for 12 weeks

Drug: placebo

Interventions

Trilipix DRUG

135 mg po daily

Also known as: fenofibric acid

Trilipix

placebo DRUG

one tablet po daily

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Triglyceride 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

You may not qualify if:

• 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 mm Hg), or changes in BP meds within prior 4 weeks, or anticipated need to change BP meds during 6-month study period
• Documented cardiovascular disease 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 Glomerular Filtration Rate \<50 ml/min)
• Hepatic disease (ALT \> 1.5x Upper Limit of Normal, 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

Sponsors & Collaborators

• University of Utah: lead
• Abbott: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Fenofibrate; fenofibric acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: Scott Low
• Organization: University of Utah

scott.low@hsc.utah.edu

801-585-1380

Study Officials

• Eliot Brinton, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 3, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 1, 2016
• Results First Posted: September 1, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)