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Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn

Persistent Pulmonary Hypertension of the Newborn Clinical Trial

Official title:
Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study

Clinical Trial Summary

This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).

Clinical Trial Description

This study was designed to investigate if the addition of Remodulin reduced the rate of clinical worsening (defined as the need for additional treatment targeting PPHN, need for extracorporeal mechanical oxygenation [ECMO], or death) in neonatal subjects with PPHN who did not show an adequate response to inhaled nitric oxide (iNO). This study was part of a pediatric investigation plan agreed upon by the EMA (EMEA 000207-PIP01-08-M08). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02261883
Study type Interventional
Source United Therapeutics
Contact
Status Terminated
Phase Phase 2
Start date July 29, 2015
Completion date May 17, 2023
View Details
See also
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