A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
NCT ID: NCT00891293
Last Updated: 2011-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
93 participants
INTERVENTIONAL
2006-03-31
2008-05-31
Brief Summary
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Detailed Description
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Studies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Interventions
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Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Eligibility Criteria
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Exclusion Criteria
* fasting serum TG levels ≥500 mg/dL and \<1300 mg/dL
* BMI ≥ 25 kg/m2 and ≤43 kg/m2.
Subjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.
18 Years
79 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK Clinical Disclosure
Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Spring Valley, California, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Coral Gables, Florida, United States
GSK Investigational Site
Hollywood, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Longwood, Florida, United States
GSK Investigational Site
Pinellas Park, Florida, United States
GSK Investigational Site
Duhwoody, Georgia, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Bloomington, Indiana, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Auburn, Maine, United States
GSK Investigational Site
Scarborough, Maine, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Wentzville, Minnesota, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Hickory, North Carolina, United States
GSK Investigational Site
Salisbury, North Carolina, United States
GSK Investigational Site
Statesville, North Carolina, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Cumberland, Rhode Island, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, United States
GSK Investigational Site
Bristol, Tennessee, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Winchester, Virginia, United States
Countries
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References
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Roth EM, Bays HE, Forker AD, Maki KC, Carter R, Doyle RT, Stein EA. Prescription omega-3 fatty acid as an adjunct to fenofibrate therapy in hypertriglyceridemic subjects. J Cardiovasc Pharmacol. 2009 Sep;54(3):196-203. doi: 10.1097/FJC.0b013e3181b0cf71.
Other Identifiers
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111821
Identifier Type: -
Identifier Source: org_study_id
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