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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Fenofibrate; Niacin

Criteria

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