An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients

NCT ID: NCT01725646

Last Updated: 2014-05-19

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

PHASE3

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-08-31

Brief Summary

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1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients

Detailed Description

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The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.

Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omacor® 4 g

Subjects in this group will take 4 g of Omacor® everyday.

Group Type ACTIVE_COMPARATOR

Omacor®

Intervention Type DRUG

Subjects in 4 g and 2 g Omacor® will take this drug

Omacor® 2 g

Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.

Group Type ACTIVE_COMPARATOR

Omacor®

Intervention Type DRUG

Subjects in 4 g and 2 g Omacor® will take this drug

Placebo

Subjects in this group will take 4 g of placebo everyday.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects in placebo group will take this drug

Interventions

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Omacor®

Subjects in 4 g and 2 g Omacor® will take this drug

Intervention Type DRUG

Placebo

Subjects in placebo group will take this drug

Intervention Type DRUG

Other Intervention Names

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Omega-3-acid ethyl ester 90 Olive oil

Eligibility Criteria

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Inclusion Criteria

* Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL

Exclusion Criteria

* Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis
* Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Excelsior

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chuen-Den Tseng, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

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Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, Taiwan, Taiwan

Site Status

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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OM3-99001

Identifier Type: -

Identifier Source: org_study_id

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