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 2 Extensions

Condition(s) targeted: Hypertriglyceridemia

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

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated With Antara, Followed by 2 Extensions

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

Primary outcome: Change in serum triglycerides

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

- Triglyceride levels between 500 and 1000 mg/dL

- Body mass index between 25 and 40 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)

Reliant Investigational Site, Spring Valley, California 91978, United States

Reliant Investigational Site, Washington, District of Columbia 20037, United States

Reliant Investigational Site, Hollywood, Florida 33023, United States

Reliant Investigational Site, Longwood, Florida 32779, United States

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Reliant Investigational Site, Evansville, Indiana 47714, United States

Reliant Investigational Site, Indianapolis, Indiana 46260, United States

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Reliant Investigational Site, Baltimore, Maryland 21201, United States

Reliant Investigational Site, Wentzville, Missouri 63385, United States

Reliant Investigational Site, Kansas City, Missouri 64111, United States

Reliant Investigational Site, St. Louis, Missouri 63110, United States

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Reliant Investigational Site, Hickory, North Carolina 28601, United States

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Reliant Investigational Site, Statesville, North Carolina 28677, United States

Reliant Investigational Site, Cincinnati, Ohio 45229, United States

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Reliant Investigational Site, Cumberland, Rhode Island 02864, United States

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Reliant Investigational Site, Bristol, Tennessee 37620, United States

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Reliant Investigational Site, Norfolk, Virginia 23502, United States

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