Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
The purpose of OM5/LOV111859 was 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 t...
Detailed Description
Three studies comprise this OM5 Program * Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636. * St...
Eligibility Criteria
Inclusion
- For OM5/LOV111858 -
- Men and women ages 18-79 years, inclusive
- 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
- 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)
- For OM5X/LOV111859 -
- Subjects were included in the study if they met the following criteria:
- Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation
- Successfully completed the previous OM5 double-blind study to Week 8
- 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)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00246636
Start Date
October 1 2005
End Date
March 1 2007
Last Update
December 14 2009
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