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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:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01122355
First received: May 12, 2010
Last updated: May 28, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122355

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

No publications provided

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
Study First Received: May 12, 2010
Last Updated: May 28, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013