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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01122355
First Posted: May 13, 2010
Last Update Posted: May 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122355


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

Responsible Party: Sang Hak Lee/associate professor, Yonsei University, College of Medicine
ClinicalTrials.gov Identifier: NCT01122355     History of Changes
Other Study ID Numbers: 4-2008-0530
First Submitted: May 12, 2010
First Posted: May 13, 2010
Last Update Posted: May 31, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Niacin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs