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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02244528
Other study ID # 14172MFDS178-1
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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