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 an 8-week Extension
NCT ID: NCT00246636
Last Updated: 2009-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
167 participants
INTERVENTIONAL
2005-10-31
2007-03-31
Brief Summary
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The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.
Detailed Description
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* Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636.
* Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OM5/LOV111859 (double-blind study) - Antara
Antara (fenofibrate) + placebo
Antara (fenofibrate)
Antara (fenofibrate) + placebo
OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Antara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Antara (fenofibrate)
Antara (fenofibrate) + placebo
OM5/LOV111859 (double-blind study) - Antara + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Antara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Interventions
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Antara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
Antara (fenofibrate)
Antara (fenofibrate) + placebo
Eligibility Criteria
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Inclusion Criteria
* Triglyceride levels between 500 mg/dL and \<1300 mg/dL
* Body mass index between 25 and 43 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
* 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)
For OM5X/LOV111859 -
Subjects were included in the study if they met the following criteria:
2. Successfully completed the previous OM5 double-blind study to Week 8
3. Provided written informed consent on or before the Week 8 clinic visit of the OM5 double-blind study (i.e., Visit 1X of the OM5X extension study)
18 Years
79 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Countries
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References
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Bays HE, Maki KC, Doyle RT, Stein E. The effect of prescription omega-3 fatty acids on body weight after 8 to 16 weeks of treatment for very high triglyceride levels. Postgrad Med. 2009 Sep;121(5):145-50. doi: 10.3810/pgm.2009.09.2061.
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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OM5/LOV111859 (original study)
Identifier Type: -
Identifier Source: secondary_id
OM5X/LOV111860 (1st extension)
Identifier Type: -
Identifier Source: secondary_id
OM5 program (Reliant)
Identifier Type: -
Identifier Source: org_study_id