At a glance
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OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (Previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects
In Brief
A Phase 3 clinical trial evaluating Simvastatin + Lovaza® (omega-3-acid ethyl esters) for Hypertriglyceridemia. Completed, enrolled 188 participants across 40 sites.
Detailed Summary
In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) \[formerly known as Omacor\] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
Study Details
Timeline
Interventions
Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]