NCT00891293

A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.

Detailed description

Three studies comprise this program. Study LOV111859/OM5 (double-blind study) was followed by two open label extensions - LOV111860/OM5X (1st open label extension - 8 weeks) and LOV111821/OM5XX (2nd open label extension - 24 months). Studies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.

Conditions

• Hypertriglyceridemia

Interventions

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

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2009-05-01
• Last updated: 2011-01-25
• Results posted: 2009-07-28

Locations

32 sites across 1 country: United States