NCT01720524

A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 0 Days – 4 Days
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

Conditions

• Pulmonary Hypertension, Familial Persistent, of the Newborn

Interventions

Type	Name	Description
DRUG	placebo	IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.
DRUG	iv sildenafil	loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.

Timeline

• Start date: 2013-08-05
• Primary completion: 2018-10-17
• Completion: 2020-09-28
• First posted: 2012-11-02
• Last updated: 2021-08-16
• Results posted: 2020-03-25

Locations

42 sites across 12 countries: United States, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom