Phase III Trial of Add-on Epanova™ to Statin Therapy in Patients with Hypertriglyceridemia. The study is a randomized, double-blind, placebo-controlled, parallel group design that will be randomizing 642 subjects with hypertriglyceridemia and high risk for cardiovascular disease (CVD). There will be six clinic visits. Subjects will undergo an initial 6-week diet lead-in period during which they will discontinue use of any non-statin lipid therapies that can be stopped, continue their current statin regimen and follow the National Cholesterol Education Program (NCEP) Therapeutics Lifestyles Changes (TLC) diet. After the statin/diet lead-in period, subjects with a fasting TG level ≥200 and <500 mg/dL who meet all Inclusion Criteria and no Exclusion Criteria will be randomized 1:1:1 to receive either double-blinded Epanova (2 g or 4 g daily) or a matching placebo (4g daily) for 6 weeks.
Pivotal Phase III Study of Epanova™ in Patients with Very High Triglycerides. The multi-center, placebo-controlled, randomized, double-blind, 12-week study will evaluate the efficacy and safety of three doses of Epanova in patients with fasting triglyceride (TG) levels of ≥500 mg/dL. The trial is expected to enroll approximately 300 patients and will be conducted in centers throughout North America, Europe and India. The primary endpoint of the trial, known as EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs), is the percentage change in triglyceride level from baseline to week 12.
Pharmacokinetics study to evaluate the bioavailability of Epanova™ in comparison to Lovaza. The primary objective of the four-week study, called ECLIPSE (Epanova
Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation), is to compare the bioavailability of EPA from Epanova and Lovaza in either a low or high fat diet setting. It is a randomized, open-label, four-way cross-over pharmacokinetics study which will include 50 subjects. In the four cross-over periods, all subjects will be given a single 4-gram dose of either Epanova or Lovaza with low and high fat meals. The trial is complete and data was released on January 7, 2011.