An Efficacy and Safety Study 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

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taichung Veterans General Hospital, Taichung, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omacor®

Drug

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

Other names: Omega-3-acid ethyl ester 90

Placebo

Drug

Subjects in placebo group will take this drug

Other names: Olive oil

Primary outcomes

Change in Triglycerides from baseline

Time frame: baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Excelsior

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Nov 14, 2012
Registry last updated: May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed