Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart Institute, Mexico
ClinicalTrials.gov Identifier:
NCT00552747
First received: November 1, 2007
Last updated: March 9, 2011
Last verified: May 2008

November 1, 2007
March 9, 2011
October 2007
March 2010   (final data collection date for primary outcome measure)
endothelial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
endothelial function [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00552747 on ClinicalTrials.gov Archive Site
  • HDL particle distribution [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • HDL associated antioxidant capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • HDL particle distribution [ Time Frame: 8 weeks ]
  • HDL associated antioxidant capacity [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease
The Effect of Fenofibrate on Endothelial Function and HDL in Patients With Coronary Heart Disease and LDL-C at Goal

Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and decreasing triglyceride levels. The interaction with these receptors has antiatherogenic actions by regulating the expression con key proteins that participate in vascular inflammation, plaque stability and thrombosis.

Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small, dense LDL particles. The use of this drug has resulted in improvement of vascular function measured by endothelial function. Our hypotheses state that fenofibrate will improve: endothelial function, improve HDL antioxidant capacity and size distribution towards a predominance of small HDL particles.

Patients with stable coronary heart disease, with LDL-C levels at goal will be invited to participate in this randomized, double blind study to receive either placebo or fenofibrate in addition to their statin therapy.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Coronary Heart Disease
  • Hyperlipidemia
  • Drug: fenofibrate
    fenofibrate 160 mg capsules qd
    Other Name: fenofibrate
  • Drug: placebo
    capsules placebo
    Other Name: placebo
  • Active Comparator: 1
    fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day
    Intervention: Drug: fenofibrate
  • Placebo Comparator: 2
    placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
January 2011
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients 18-60 years of age
  • Stable coronary heart disease (no cardiovascular event 3 months prior to enrollment)
  • Stable lipid-modifying drug therapy (previous 2 months)
  • Low-dose statin therapy with LDL-C at goal (< 100 mg/dl)
  • Triglyceride levels 151-500 mg/dl
  • HDL-C levels <40 mg/dl

Exclusion Criteria:

  • Diabetes mellitus
  • Uncontrolled hypertension Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg
  • Subjects with renal (serum creatinine >1.5 times the upper limit of normal (ULN)), hepatobiliary (cholelithiasis, biliary cirrhosis, AST and/or ALT >2x ULN) or active thyroid disease (TSH >1.5x ULN or <0.05 uUI/ml)
  • Hypersensitivity to fenofibrate or to any other component of its formula
  • History of photoallergic reaction or phototoxicity to fenofibrate or ketoprofen
Male
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00552747
fenofibrate
Yes
Carlos Posadas-Romero MD, National Institute of Cardiology
National Heart Institute, Mexico
Not Provided
Principal Investigator: Carlos Posadas-Romero, MD principal investigator
Study Director: Pedro Reyes, MD head bioethics committee
National Heart Institute, Mexico
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP