Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Simvastatin; Drug: Simvastatin + Lovaza

• Registration Number: NCT00246701
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.

Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

Detailed Description

Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409.

Study Timeline

• Study First Submitted: 2005-10-28
• Study First Submitted QC: 2005-10-28
• Study First Posted: 2005-10-30
• Study Start: 2005-11-01
• Primary Completion: 2006-06-01
• Study Completion: 2006-06-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin	Simvastatin + placebo
Simvastatin + Lovaza	Simvastatin + Lovaza	Simvastatin + Lovaza (omega-3-acid ethyl esters)

Primary Outcome Measures

Name	Time	Method
Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol	8 weeks

Secondary Outcome Measures

Name	Time	Method
OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels	8 weeks