Status:
COMPLETED
PK Study of Sildenafil in Neonate
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
Conditions:
Neonates and Preterm Infants
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
- Infants who were diagnosed with PAH
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02244528
Start Date
October 1 2014
End Date
October 1 2016
Last Update
October 16 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
2
Seoul National University Children's Hospital
Seoul, South Korea, 110-744