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

May 28, 2010 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percent change of apoB/A1
Time Frame: after 16 weeks of drug treatment
after 16 weeks of drug treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Sang Hak Lee, professor of division of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 12, 2010

First Posted (Estimate)

May 13, 2010

Study Record Updates

Last Update Posted (Estimate)

May 31, 2010

Last Update Submitted That Met QC Criteria

May 28, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2008-0530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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