Amarin Corp. (AMRN) Says Publication of ANCHOR Phase 3 Results Available
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Amarin Corporation plc (Nasdaq: AMRN) reports that the results of its pivotal ANCHOR Phase 3 clinical trial are now available electronically through The American Journal of Cardiology and are scheduled for print publication in the October 2012 issue.
The publication, titled "Efficacy and Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Statin-Treated Patients With Persistent High Triglycerides (from the ANCHOR study)," describes the previously reported results of the Phase 3 ANCHOR clinical trial of Amarin's product candidate AMR101, in which all primary and secondary endpoints were achieved.
The ANCHOR trial, a multicenter, placebo-controlled, randomized, double-blind, 12-week study, investigated AMR101 as a treatment for high triglycerides (≥200 and <500mg/dL) in 702 patients with mixed dyslipidemia (two or more lipid disorders) on background statin therapy at LDL-C (low-density lipoprotein cholesterol) goal who were at high risk of cardiovascular disease. The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The trial's primary endpoint was defined as the percentage change in triglyceride levels from baseline compared to placebo after twelve weeks of treatment.
The publication, titled "Efficacy and Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Statin-Treated Patients With Persistent High Triglycerides (from the ANCHOR study)," describes the previously reported results of the Phase 3 ANCHOR clinical trial of Amarin's product candidate AMR101, in which all primary and secondary endpoints were achieved.
The ANCHOR trial, a multicenter, placebo-controlled, randomized, double-blind, 12-week study, investigated AMR101 as a treatment for high triglycerides (≥200 and <500mg/dL) in 702 patients with mixed dyslipidemia (two or more lipid disorders) on background statin therapy at LDL-C (low-density lipoprotein cholesterol) goal who were at high risk of cardiovascular disease. The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The trial's primary endpoint was defined as the percentage change in triglyceride levels from baseline compared to placebo after twelve weeks of treatment.
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