NCT00903409

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Simvastatin + Lovaza® (omega-3-acid ethyl esters)	Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]

Timeline

• Start date: 2005-11-15
• Primary completion: 2008-06-27
• Completion: 2008-06-27
• First posted: 2009-05-18
• Last updated: 2017-10-09
• Results posted: 2009-08-04

Locations

40 sites across 1 country: United States