Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-Acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects Followed by a 2 Year Extension.

Condition(s) targeted: Hypertriglyceridemia

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

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Reliant ClinicalTrials.gov Call Center, Study Director, Affiliation: Reliant Pharmaceuticals

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.

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.

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

Primary outcome: Change in non-high-density lipoprotein cholesterol

Secondary outcome: Changes in other lipid and biomarker levels

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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)

Reliant Investigational Site, Mobile, Alabama 36608, United States

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Starting date: May 2005
Last updated: May 30, 2008