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

Phase 4

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Antara (fenofibrate); Drug: Antara (fenofibrate) + Lovaza

• Registration Number: NCT00246636
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-28
• Study First Submitted QC: 2005-10-28
• Study First Posted: 2005-10-30
• Primary Completion: 2007-02
• Study Completion: 2007-03
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-10
• Last Update Posted: 2009-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OM5/LOV111859 (double-blind study) - Antara	Antara (fenofibrate)	Antara (fenofibrate) + placebo
OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza	Antara (fenofibrate) + Lovaza	Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza	Antara (fenofibrate)	Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
OM5/LOV111859 (double-blind study) - Antara + Lovaza	Antara (fenofibrate) + Lovaza	Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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