Trial | NCT01725646  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    253
Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients
Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients
The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.
Study Started
Jul 31
2011
Primary Completion
Jul 31
2013
Study Completion
Aug 31
2013
Last Update
May 19
2014
Estimate

Drug Omacor®

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

  • Other names: Omega-3-acid ethyl ester 90

Drug Placebo

Subjects in placebo group will take this drug

  • Other names: Olive oil

Omacor® 4 g Active Comparator

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

Omacor® 2 g Active Comparator

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

Placebo Placebo Comparator

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

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
No Results Posted