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

Study Overview
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Brief Summary
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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.

Detailed Description
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Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.

Official Title
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OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (Previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)


Participation Criteria
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Eligibility Criteria
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For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8. FYI - entry criteria for LOV111818/OM6 (double-blind study) 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: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin + Lovaza® (Non-switchers)<br>Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + Lovaza® in the double-blind trial, hence in this open-label extension, they are termed Non-switchers | Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)<br>* Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]<br>|
| Experimental: Simvastatin + Lovaza® (Switchers)<br>Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + placebo in the double-blind trial, hence in this open-label extension, they are termed Switchers | Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)<br>* Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818) | Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial) | Month 4 (LOV111818) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in Switchers vs. Non-switchers | Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial | Months 4, 12, and 24 (LOV111818) of the open-label extension trial | 
| Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial | Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial | LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial | 

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