Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension

Study Overview
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Brief Summary
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The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides. The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.

Detailed Description
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Three studies comprise this OM5 Program Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636. Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated With Antara, Followed by an 8-week Extension

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Antara (fenofibrate) + Lovaza
* Drug: Antara (fenofibrate)


Participation Criteria
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Eligibility Criteria
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For OM5/LOV111858 - Inclusion Criteria: Men and women ages 18-79 years, inclusive Triglyceride levels between 500 mg/dL and <1300 mg/dL Body mass index between 25 and 43 kg/m2 Willingness to follow a low-saturated fat diet during the study period and maintain current physical activity level 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 fibrate drugs or omega-3 fatty acids Lipoprotein lipase impairment or apo C-2 deficiency or Type III hyperlipidemia History of pancreatitis Recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer (except non-melanoma skin cancer) Poorly controlled diabetes mellitus Type 1 diabetes 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 isotretinoin (Accutane) Use of warfarin (Coumadin) For OM5X/LOV111859 - Subjects were included in the study if they met the following criteria: Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation Successfully completed the previous OM5 double-blind study to Week 8 Provided written informed consent on or before the Week 8 clinic visit of the OM5 double-blind study (i.e., Visit 1X of the OM5X extension study)

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: OM5/LOV111859 (double-blind study) - Antara<br>Antara (fenofibrate) + placebo | Drug: Antara (fenofibrate)<br>* Antara (fenofibrate) + placebo<br>|
| Experimental: OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza<br>Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] | Drug: Antara (fenofibrate) + Lovaza<br>* Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]<br>Drug: Antara (fenofibrate)<br>* Antara (fenofibrate) + placebo<br>|
| Experimental: OM5/LOV111859 (double-blind study) - Antara + Lovaza<br>Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] | Drug: Antara (fenofibrate) + Lovaza<br>* Antara (fenofibrate) + 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 |
| --- | --- | --- |
| OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X |  | 8 weeks | 
| OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5X |  | 8 weeks | 
| OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline |  | 8 weeks | 

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