Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.

Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)