drugset / Trial / NCT03142568
Safety of Sildenafil in Premature Infants
Phase 2
Completed
109 enrolled
University of North Carolina, Chapel Hill
Duke University · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabThe Emmes Company, LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding Source - FDA Office of Orphan Products Development (OOPD).
Timeline
- Start
- 2018-04-02
- Primary completion
- 2025-03-01
- Completion
- 2025-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sildenafil | Unknown | 0.125 mg/kg | Intravenous |
| Subject | Sildenafil | Unknown | 0.25 mg/kg | Intravenous |
| Subject | Sildenafil | Unknown | 0.5 mg/kg | Intravenous |
| Subject | Sildenafil | Unknown | 1 mg/kg | Intravenous |
| Subject | Sildenafil | Unknown | 2 mg/kg | Intravenous |