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

Excelsior

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: Placebo; Drug: Omacor®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01725646

OM3-99001

Details and patient eligibility

About

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

Full description

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

Enrollment: 253 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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253 participants in 3 patient groups, including a placebo group

Omacor® 4 g

Active Comparator group

Description:

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

Treatment:

Drug: Omacor®

Omacor® 2 g

Active Comparator group

Description:

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

Treatment:

Drug: Omacor®

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo