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
Hypertriglyceridemia
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Very high triglycerides, omega-3-acid ethyl esters, fenofibrate, Lovaza
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
OM5/LOV111859 (double-blind study) - Antara
OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
OM5/LOV111859 (double-blind study) - Antara + Lovaza
Antara (fenofibrate) + placebo
Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]