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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00552747

Enrollment

Registered

2007-11-02

Start date

2007-10-31

Completion date

2011-01-31

Last updated

2011-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Hyperlipidemia

Keywords

fenofibrate, coronary heart disease, mixed hyperlipidemia

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.

Detailed description

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.

Interventions

DRUGfenofibrate

fenofibrate 160 mg capsules qd

DRUGplacebo

capsules placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
endothelial function	8 weeks

Secondary

Measure	Time frame
HDL particle distribution	8 weeks
HDL associated antioxidant capacity	8 weeks

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026