PK Study of Sildenafil in Neonate

Neonates and Preterm Infants Clinical Trial

Official title:

Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244528
• Other study ID #: 14172MFDS178-1
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2014
• Last updated: October 13, 2017
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Neonates and Preterm Infants
• Premature Birth

Intervention

Drug:
• Sildenafil

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-t)	5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics	t up to 5 weeks
Primary	Cmax(0-t)	5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics	t up to 5 weeks
Secondary	Change from baseline in pulmonary arterial hypertension at 5 weeks	Echocardiography; RV systolic pressure: TR velocity2 x 4; Septum contour: normal, flat at end-systole, flat at end-diastole; LV shape: normal, partially D-shape, D-shape, squeezed; LV eccentricity index; RV area/LV area (Apical 4 chamber view, at end diastole); RA enlargement (Apical 4 chamber view); RV anterior wall thickness; TAPSE (Tricuspid annular plane systolic excursion); RV Tei index (by tissue Doppler); Tissue Doppler velocity at RV free wall	pre, 2 weeks, 5 weeks of drug administration
Secondary	respiratory severity score	Mean airway pressure x FiO2	pre, 2 weeks, 5 weeks after administration