Study of Trilipix Effects on Lipids and Arteries

Dyslipidemia Clinical Trial

Official title:

Mechanisms of Atheroprotection by Fenofibric Acid (ABT 335) Added to a Statin in Subjects With Insulin Resistance (Hypertriglyceridemia and Low HDL-C)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01025492
• Other study ID #: 00030151
• Status: Terminated
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: July 27, 2011
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: July 2011
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Trilipix (fenofibric acid)
135 mg po daily
• placebo
one tablet po daily

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL composition		12 weeks	No