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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fenofibrate

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:

1. Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation

2. Successfully completed the previous OM5 double-blind study to Week 8

3. 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)