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 an 8-week Extension
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 167
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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)
Arms & Interventions
OM5/LOV111859 (double-blind study) - Antara
Antara (fenofibrate) + placebo
Intervention: Antara (fenofibrate) (Drug)
OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention: Antara (fenofibrate) + Lovaza (Drug)
OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention: Antara (fenofibrate) (Drug)
OM5/LOV111859 (double-blind study) - Antara + Lovaza
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention: Antara (fenofibrate) + Lovaza (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: 8 weeks
Secondary Outcomes
- 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)