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Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure — RELAX-PEDS-PK  

Acute Heart Failure Clinical Trial

Official title:
Multicenter, Open-label, Dose Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of RLX030 in Addition to Standard of Care in Pediatric Patients From Birth to <18 Years of Age, Hospitalized With Acute Heart Failure

Clinical Trial Summary

The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)

Clinical Trial Description

The study was terminated early and the pediatric development of serelaxin in the treatment of acute heart failure (AHF) discontinued, following the results of the phase III study RELAX-AHF-2 (CRLX030A2301/NCT01870778) study in adult patients with AHF. Whilst no new safety concerns associated with serelaxin were observed, the study in adults did not meet either of its primary endpoints ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02151383
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Phase 2
Start date September 5, 2014
Completion date April 3, 2017
View Details
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