Hypertriglyceridemia
Conditions
Keywords
Very high triglycerides, omega-3-acid ethyl esters, fenofibrate, Lovaza
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 triglycerides. 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
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. * Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293
Interventions
DRUGAntara (fenofibrate) + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]
DRUGAntara (fenofibrate)
Antara (fenofibrate) + placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
For OM5/LOV111858 - Inclusion Criteria: * 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 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) For OM5X/LOV111859 - Subjects were included in the study if they met the following criteria: 1. Satisfied all inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X | 8 weeks |
| OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5X | 8 weeks |
| OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline | 8 weeks |
Outcome results
None listed