Official Title: “A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects Followed by a 2 Year Extension.”

The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with simvastatin for lowering non-high-density lipoprotein cholesterol in subjects with persistent high triglycerides despite statin therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2006

Intervention(s) in this Clinical Trial

• Drug: simvastatin plus Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
• Drug: simvastatin

Primary Measures

• Change in non-high-density lipoprotein cholesterol

Secondary Measures

• Changes in other lipid and biomarker levels

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Call Centre Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00246701

Study ID Number: OM6 program (Reliant)

ClinicalTrials.gov Identifier: NCT00246701

Health Authority: United States: Food and Drug Administration