NCT00552747

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 10, 2011

Status Verified

May 1, 2008

Enrollment Period

2.4 years

First QC Date

November 1, 2007

Last Update Submit

March 9, 2011

Conditions

Coronary Heart DiseaseHyperlipidemia

Keywords

fenofibratecoronary heart diseasemixed hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • endothelial function

    8 weeks

Secondary Outcomes (2)

  • HDL particle distribution

    8 weeks

  • HDL associated antioxidant capacity

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

fenofibrate 160 mg capsules (QD) Taken once daily with the largest meal of the day

Drug: fenofibrate

2

PLACEBO COMPARATOR

placebo (capsules identical to those of fenofibrate) taken once daily (QD)with the largest meal of the day

Drug: placebo

Interventions

fenofibrateDRUG

fenofibrate 160 mg capsules qd

1
placeboDRUG

capsules placebo

2

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology Department National Institute of Cardiology Ignacio Chavez

Mexico City, 14080, Mexico

Location

Related Publications (8)

  • Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994 Nov 19;344(8934):1383-9.

    PMID: 7968073BACKGROUND

  • Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med. 1995 Nov 16;333(20):1301-7. doi: 10.1056/NEJM199511163332001.

    PMID: 7566020BACKGROUND

  • Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996 Oct 3;335(14):1001-9. doi: 10.1056/NEJM199610033351401.

    PMID: 8801446BACKGROUND

  • Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, Langendorfer A, Stein EA, Kruyer W, Gotto AM Jr. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998 May 27;279(20):1615-22. doi: 10.1001/jama.279.20.1615.

    PMID: 9613910BACKGROUND

  • Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.

    PMID: 15007110BACKGROUND

  • LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352(14):1425-35. doi: 10.1056/NEJMoa050461. Epub 2005 Mar 8.

    PMID: 15755765BACKGROUND

  • Gordon DJ, Probstfield JL, Garrison RJ, Neaton JD, Castelli WP, Knoke JD, Jacobs DR Jr, Bangdiwala S, Tyroler HA. High-density lipoprotein cholesterol and cardiovascular disease. Four prospective American studies. Circulation. 1989 Jan;79(1):8-15. doi: 10.1161/01.cir.79.1.8.

    PMID: 2642759BACKGROUND

  • Hokanson JE, Austin MA. Plasma triglyceride level is a risk factor for cardiovascular disease independent of high-density lipoprotein cholesterol level: a meta-analysis of population-based prospective studies. J Cardiovasc Risk. 1996 Apr;3(2):213-9.

    PMID: 8836866BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary DiseaseHyperlipidemiasHyperlipoproteinemia Type II

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemias

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • Carlos Posadas-Romero, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

  • Pedro Reyes, MD

    head bioethics committee

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 2007

First Posted

November 2, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2010

Study Completion

January 1, 2011

Last Updated

March 10, 2011

Record last verified: 2008-05

Locations

ME(1)