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Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF — RELAX-AHF-2  

Acute Heart Failure Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

Clinical Trial Summary

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

Clinical Trial Description

This Phase IIIb outcome study in AHF patients was designed as a multicenter, randomized, double-blind, placebo-controlled, event-driven study in order to assess the efficacy, safety and tolerability of intravenous infusion of serelaxin or placebo. The AHF patients randomized to either serelaxin or placebo in the study were followed for a period of 180 days, and were required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01870778
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date October 2, 2013
Completion date February 1, 2017
View Details
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