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™

Completed · Phase 4

Conditions studied: Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT00891293

Run by

GlaxoSmithKline

People needed

93

Starts

2006-03-01

Expected to finish

2008-05-01

Last updated by the study team

2011-01-25

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Coral Gables, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Longwood, Florida, United States
• GSK Investigational Site — Pinellas Park, Florida, United States
• GSK Investigational Site — Duhwoody, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Bloomington, Indiana, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Auburn, Maine, United States
• GSK Investigational Site — Scarborough, Maine, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Wentzville, Minnesota, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Hickory, North Carolina, United States
• GSK Investigational Site — Salisbury, North Carolina, United States
• GSK Investigational Site — Statesville, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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