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

Phase 4

Completed

• Conditions: Hypertriglyceridemia With Low HDL-cholesterol
• Interventions: Drug: lipid modification

• Registration Number: NCT01122355
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Last Update Submitted: 2010-05-28
• Last Update Posted: 2010-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
niacin arm	lipid modification	-
fenofibrate arm	lipid modification	-

Primary Outcome Measures

Name	Time	Method
percent change of apoB/A1	after 16 weeks of drug treatment