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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Hypertriglyceridemia With Low HDL-cholesterol

Treatments: Drug: lipid modification

Study type: Interventional

Funder types: Other

Identifiers

NCT01122355

4-2008-0530

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

niacin arm

Active Comparator group

Treatment:

Drug: lipid modification

fenofibrate arm

Active Comparator group

Treatment:

Drug: lipid modification