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Brief description/objective

A multicenter, randomized, double-blind, placebocontrolled
phase III study to evaluate the efficacy, safety
and tolerability of Serelaxin when added to standard
therapy in acute heart failure patients

The purpose of this study is to evaluate the efficacy, safety and tolerability
of intravenous infusion of 30 μg/kg/day serelaxin administered by body
weight category (Table 5-3) for 48 hours, when added to standard therapy,
in approximately 6,375 acute heart failure (AHF) patients. Efficacy will be
determined based on the relative reduction in CV death and other clinical
outcomes through a follow-up period of 180 days, as compared to
placebo.
The rate of mortality in AHF remains high despite contemporary standardof-
care management, which has not changed significantly in the last 10
years, and represents a key unmet need for AHF patients. In the RELAX
AHF trial a clinically and statistically significant 37% reduction in both CV
and all-cause mortality through Day 180 were seen. Data from this study
is intended to replicate the reduction in mortality in AHF patients observed
in the RELAX AHF trial.