Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol

Yonsei University240 enrolled

Overview

The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary end point is the percent change of apoB/A1 and the secondary end points are other lipid parameters and biomarkers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Hypertriglyceridemia With Low HDL-cholesterol

Interventions

lipid modificationDRUG

1\) fenofibrate 160 mg po for 16 weeks, 2) niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Triglyceride 150-500 mg/dL and HDL-cholesterol \< 45 mg/dL after 8 week dietary run in period * 20-79 years old Exclusion Criteria: * Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug * History of cerebrovascular or cardiovascular diseases * Creatinine \> 2.0 mg/dL * Transaminase \> 2x upper limit of normal * Gall bladder disease * Cancer * Pregnant or breast feeding women * History of adverse events associated with test drugs

Outcomes

Primary Outcomes

percent change of apoB/A1

Time frame: after 16 weeks of drug treatment

Data from ClinicalTrials.gov

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