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news.Amgen, in collaboration with Cytokinetics, has started recruiting patients in a international, multicenter, randomized, double-blind, placebo-controlled Phase IIb clinical trial of an intravenous formulation of omecamtiv mecarbil.
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The trial is designed to investigate the safety and efficacy of omecamtiv mecarbil in patients with left ventricular systolic dysfunction who are hospitalized for acute heart failure.
In the trial, around 600 patients, recruited in 3 sequential, ascending-dose cohorts.
In each cohort, patients will be randomized to receive omecamtiv mecarbil or placebo.
Cytokinetics Clinical Research and Development senior vice president and chief medical officer Andrew Wolff said the objective of this trial is to determine if the increases in left ventricular systolic function observed in patients with stable heart failure treated with omecamtiv mecarbil in an earlier Phase IIa trial may translate into clinically beneficial outcomes in patients hospitalized for acute heart failure.