PK Study of Sildenafil in Neonate

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Seoul National University Bundang Hospital
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital

• Infants who were diagnosed with PAH

Exclusion Criteria:

• Severe allergic reaction to sildenafil

• Inotropics for hypotension within 3 days prior to enrollment

• AST or ALT > 3x ULN

• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud