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

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Omacor®; Drug: Placebo

• Registration Number: NCT01725646
• Lead Sponsor: Excelsior

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-14
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omacor® 4 g	Omacor®	Subjects in this group will take 4 g of Omacor® everyday.
Omacor® 2 g	Omacor®	Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.
Placebo	Placebo	Subjects in this group will take 4 g of placebo everyday.

Primary Outcome Measures

Name	Time	Method
Change in Triglycerides from baseline	baseline and 8 weeks

Trial Locations

Locations (4)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan