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

Completed · Phase 3

Conditions studied: Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT00903409

Run by

GlaxoSmithKline

People needed

188

Starts

2005-11-15

Expected to finish

2008-06-27

Last updated by the study team

2017-10-09

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Encinitas, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Greenbrae, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Thousand Oaks, California, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Pinellas Park, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Dunwoody, Georgia, United States
• GSK Investigational Site — Suwanee, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Bloomington, Indiana, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Edina, Minnesota, United States
• GSK Investigational Site — Wentzville, Minnesota, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Hickory, North Carolina, United States
• GSK Investigational Site — Salisbury, North Carolina, United States

Full record on ClinicalTrials.gov

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