Clinical trial
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
NCT01720524 is registered in ClinicalTrials.gov with Pfizer's Upjohn has merged with Mylan to form Viatris Inc. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Phase
- Phase 3
- Overall status
- Completed
- Start date
- August 5, 2013
- Completion date
- September 28, 2020
- Enrollment
- 59 (actual)
- Sites
- 42
Conditions
As the registry lists them; a condition with its own page is linked.
pulmonary hypertension, familial persistent, of the newborn