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

This study has been completed.
Information provided by:
Yonsei University Identifier:
First received: May 12, 2010
Last updated: May 28, 2010
Last verified: May 2010
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.

Condition Intervention Phase
Hypertriglyceridemia With Low HDL-cholesterol
Drug: lipid modification
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • percent change of apoB/A1 [ Time Frame: after 16 weeks of drug treatment ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: niacin arm Drug: lipid modification
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
Active Comparator: fenofibrate arm Drug: lipid modification
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


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01122355

Sponsors and Collaborators
Yonsei University
Principal Investigator: Sang Hak Lee professor of division of Cardiology
  More Information

Responsible Party: Sang Hak Lee/associate professor, Yonsei University, College of Medicine Identifier: NCT01122355     History of Changes
Other Study ID Numbers: 4-2008-0530 
Study First Received: May 12, 2010
Last Updated: May 28, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on October 20, 2016