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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01725646

Enrollment

253

Registered

2012-11-14

Start date

2011-07-31

Completion date

2013-08-31

Last updated

2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

Hypertriglyceridemia, omega-3-acid ethyl ester

Brief summary

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

Interventions

DRUGOmacor®

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

DRUGPlacebo

Subjects in placebo group will take this drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame
Change in Triglycerides from baseline	baseline and 8 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026