NCT02261883

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 1 Hour – 14 Days
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Persistent Pulmonary Hypertension of the Newborn

Interventions

Type	Name	Description
DRUG	IV Remodulin	Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
DRUG	Placebo	Sodium citrate, sodium chloride, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).

Timeline

• Start date: 2015-07-29
• Primary completion: 2022-09-27
• Completion: 2023-05-17
• First posted: 2014-10-10
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study