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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Simvastatin
* Drug: Simvastatin + Lovaza


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simvastatin<br>Simvastatin + placebo | Drug: Simvastatin<br>* Simvastatin<br>|
| Experimental: Simvastatin + Lovaza<br>Simvastatin + Lovaza (omega-3-acid ethyl esters) | Drug: Simvastatin + Lovaza<br>* Simvastatin + Lovaza (omega-3-acid ethyl esters)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3-acid ethyl esters, simvastatin, Lovaza, High triglycerides