Amarin (AMRN) Vascepa Met Primary Efficacy Endpoinst in Recent MARINE Phase 3
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Amarin Corporation plc (Nasdaq: AMRN), announced that additional data from its pivotal MARINE Phase 3 clinical trial are now available electronically through the Journal of Clinical Lipidology and are expected to be published in a future print issue of the journal before the end of 2012.
The publication, titled "AMR101, a Pure EPA Omega-3 Fatty Acid: Effects on Lipoprotein Particle Concentration and Size in Patients with Very High Triglyceride Levels (the MARINE Study)," reports the effects of Vascepa (icosapent ethyl) capsules (formerly referred to as AMR101) on lipoprotein particle concentrations and sizes in patients with baseline triglyceride levels ≥500 mg/dL. This publication reported that Vascepa significantly reduced median concentrations of large very-low-density lipoprotein (VLDL), total LDL, small LDL and total high-density lipoprotein (HDL) particles and reduced VLDL particle size in a patient population with TG ≥500 mg/dL. Vascepa did not significantly change the overall sizes of LDL or HDL particles.
The MARINE trial was a Phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week study. The study enrolled 229 patients and investigated Vascepa as a treatment for severe (TG ≥500 mg/dL) hypertriglyceridemia. The MARINE trial achieved its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a favorable safety profile.
The publication, titled "AMR101, a Pure EPA Omega-3 Fatty Acid: Effects on Lipoprotein Particle Concentration and Size in Patients with Very High Triglyceride Levels (the MARINE Study)," reports the effects of Vascepa (icosapent ethyl) capsules (formerly referred to as AMR101) on lipoprotein particle concentrations and sizes in patients with baseline triglyceride levels ≥500 mg/dL. This publication reported that Vascepa significantly reduced median concentrations of large very-low-density lipoprotein (VLDL), total LDL, small LDL and total high-density lipoprotein (HDL) particles and reduced VLDL particle size in a patient population with TG ≥500 mg/dL. Vascepa did not significantly change the overall sizes of LDL or HDL particles.
The MARINE trial was a Phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week study. The study enrolled 229 patients and investigated Vascepa as a treatment for severe (TG ≥500 mg/dL) hypertriglyceridemia. The MARINE trial achieved its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a favorable safety profile.
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