At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 59 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
iv sildenafil 0.1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Nov 2, 2012·Updated Aug 16, 2021
In Brief
A Phase 3 clinical trial evaluating placebo and iv sildenafil for Pulmonary Hypertension, Familial Persistent, of the Newborn. Completed, enrolled 59 participants across 42 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartAug 2013
Primary CompletionOct 2018
Study CompletionSep 2020
TodayJul 2026
First PostedNov 2, 2012
Enrollment StartAug 5, 2013
Primary CompletionOct 17, 2018
Study CompletionSep 28, 2020
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 13.7 years ago
Interventions
placebodrug
IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.
iv sildenafildrug
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.