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
Phase of Trial: Phase III
Latest Information Update: 03 Apr 2018
At a glance
- Drugs Sildenafil (Primary)
- Indications Pulmonary hypertension
- Focus Registrational; Therapeutic Use
- Sponsors Pfizer
- 27 Mar 2018 Planned End Date changed from 5 Aug 2020 to 1 Dec 2020.
- 27 Mar 2018 Planned primary completion date changed from 9 Jul 2018 to 1 Dec 2018.
- 12 Mar 2018 Planned End Date changed from 3 Aug 2020 to 5 Aug 2020.