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NCT01725646 Clinical Trial

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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01725646
Other study ID # OM3-99001
Secondary ID
Status Completed
Phase Phase 3
First received October 29, 2012
Last updated May 16, 2014
Start date July 2011
Est. completion date August 2013

Study information
Verified date May 2014
Source Excelsior
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 253
Est. completion date August 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Omacor®
Subjects in 4 g and 2 g Omacor® will take this drug
• Placebo
Subjects in placebo group will take this drug

Locations
Country Name City State
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Excelsior

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Triglycerides from baseline baseline and 8 weeks Yes
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