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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hypertriglyceridemia

Treatments: Drug: Simvastatin; Drug: Simvastatin + Lovaza

Study type: Interventional

Funder types: Industry

Identifiers

NCT00246701

OM6 program (Reliant)

LOV111818 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.

Enrollment: 256 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

Simvastatin

Active Comparator group

Description:

Simvastatin + placebo

Treatment:

Drug: Simvastatin

Simvastatin + Lovaza

Experimental group

Description:

Simvastatin + Lovaza (omega-3-acid ethyl esters)

Treatment:

Drug: Simvastatin + Lovaza