PK Study of Sildenafil in Neonate

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Neonates and Preterm Infants

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02244528

14172MFDS178-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Experimental group

Description:

sildenafil treatment

Treatment:

Drug: Sildenafil