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

May 16, 2014 updated by: Excelsior

A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital

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

18 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omacor® 4 g
Subjects in this group will take 4 g of Omacor® everyday.
Drug: Omacor®
Subjects in 4 g and 2 g Omacor® will take this drug
Other Names:
  • Omega-3-acid ethyl ester 90
Active Comparator: Omacor® 2 g
Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.
Drug: Omacor®
Subjects in 4 g and 2 g Omacor® will take this drug
Other Names:
  • Omega-3-acid ethyl ester 90
Placebo Comparator: Placebo
Subjects in this group will take 4 g of placebo everyday.
Drug: Placebo
Subjects in placebo group will take this drug
Other Names:
  • Olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Triglycerides from baseline
Time Frame: baseline and 8 weeks
baseline and 8 weeks

Collaborators and Investigators

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

Sponsor

Excelsior

Investigators

  • Principal Investigator: Chuen-Den Tseng, M.D., PhD., NTUH

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

July 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM3-99001

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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