Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
Recruiting in Palo Alto (17 mi)
+16 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: United Therapeutics
Prior Safety Data
Trial Summary
What is the purpose of this trial?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).
Eligibility Criteria
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: IV RemodulinActive Control1 Intervention
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Group II: PlaceboPlacebo Group1 Intervention
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Virginia Health Systems(UVA)Charlottesville, VA
All Children's HospitalSaint Petersburg, FL
Columbia University Medical CenterNew York, NY
Children's Mercy HospitalKansas City, MO
More Trial Locations
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Who Is Running the Clinical Trial?
United TherapeuticsLead Sponsor