Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

NCT ID: NCT01666041

Last Updated: 2014-11-04

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate

Detailed Description

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Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

fenofibrate/omega

fenofibrate/omega

Group Type ACTIVE_COMPARATOR

fenofibrate/omega

Intervention Type DRUG

fenofibrate

fenofibrate

Group Type ACTIVE_COMPARATOR

fenofibrate

Intervention Type DRUG

Interventions

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placebo

Intervention Type DRUG

fenofibrate/omega

Intervention Type DRUG

fenofibrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* hypertriglyceridemia

Exclusion Criteria

* moderate or severe hypertension, uncontrolled diabetes (HbA1c \> 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kwang Kon Koh

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gil Medical Center

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GMC-201202

Identifier Type: -

Identifier Source: org_study_id

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