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

NCT ID: NCT01122355

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertriglyceridemia With Low HDL-cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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niacin arm

Group Type ACTIVE_COMPARATOR

lipid modification

Intervention Type DRUG

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

fenofibrate arm

Group Type ACTIVE_COMPARATOR

lipid modification

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Yonsei University, College of Medicine

Principal Investigators

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Sang Hak Lee

Role: PRINCIPAL_INVESTIGATOR

professor of division of Cardiology

Other Identifiers

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4-2008-0530

Identifier Type: -

Identifier Source: org_study_id