Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects

For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8. FYI - entry criteria for LOV111818/OM6 (double-blind study) Inclusion Criteria: * Men and women ages 18-79 years, inclusive * Current therapy with a statin drug * Triglyceride levels between 200 and 499 mg/dL * Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests * Provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: * Sensitivity to statin drugs or omega-3 fatty acids * Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia * Unexplained muscle pain or weakness * History of pancreatitis * Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer) * Poorly controlled diabetes, or receiving insulin therapy * Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception. * Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs * Use of warfarin (Coumadin)