Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02261883

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
  Status Clinical Trial Phase
Completed NCT04328636 - Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn Phase 1/Phase 2
Recruiting NCT02380040 - Plethismographic Perfusion Index in Neonates N/A
Withdrawn NCT01360671 - IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn Phase 2
Completed NCT04841070 - NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn N/A
Recruiting NCT05741229 - The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns N/A
Recruiting NCT00710177 - PTGS1 Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn
Completed NCT01670136 - Pharmacokinetics of Sildenafil in Premature Infants Phase 1
Completed NCT02940327 - Markers of Inflammation and Lung Recovery in ECMO Patients for PPHN
Terminated NCT01389856 - Persistent Pulmonary Hypertension of the Newborn Phase 3
Terminated NCT01069861 - Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN) Phase 2
Active, not recruiting NCT02951130 - Milrinone in Congenital Diaphragmatic Hernia Phase 2
Enrolling by invitation NCT04938167 - Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension N/A
Not yet recruiting NCT04379180 - Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN