Back to results

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

Primary Purpose

Hypertriglyceridemia

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

Omacor®

Placebo

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Hypertriglyceridemia, omega-3-acid ethyl ester

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Taichung Veterans General Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omacor® 4 g

Omacor® 2 g

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Triglycerides from baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT01725646

First Posted

October 29, 2012

Last Updated

May 16, 2014

Sponsor

Excelsior

1. Study Identification

Unique Protocol Identification Number

NCT01725646

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Excelsior

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

Keywords

Hypertriglyceridemia, omega-3-acid ethyl ester

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

253 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omacor® 4 g

Arm Type

Active Comparator

Arm Description

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

Arm Title

Omacor® 2 g

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omacor®

Other Intervention Name(s)

Omega-3-acid ethyl ester 90

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Olive oil

Intervention Description

Subjects in placebo group will take this drug

Primary Outcome Measure Information:

Title

Change in Triglycerides from baseline

Time Frame

baseline and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

NTUH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs