27.10.2015 13:26:48
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Amgen Reports Positive Top-Line Results From Omecamtiv Mecarbil Phase 2 Trial
(RTTNews) - Amgen (AMGN) and Cytokinetics Inc. (CYTK) announced that data from the expansion phase of COSMIC-HF, a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showed statistically significant improvements in several measures of cardiac function, at 20 weeks following randomization.
The expansion phase of COSMIC-HF was designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of oral omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction.
The company said the data from the expansion phase showed that pharmacokinetic-based dose titration adequately controlled patient exposure to omecamtiv mecarbil and resulted in statistically significant decreases in cardiac dimensions and heart rate in the dose-titration group. Adverse events, including serious adverse events, in patients on omecamtiv mecarbil appeared comparable to those on placebo.
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