PK Study of Sildenafil in Neonate

Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Neonates and Preterm Infants
• Intervention / Treatment: Drug: Sildenafil

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Children's Hospital
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; sildenafil treatment	Drug: Sildenafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-t)	5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics	t up to 5 weeks
Cmax(0-t)	5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics	t up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
respiratory severity score	Mean airway pressure x FiO2	pre, 2 weeks, 5 weeks after administration

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: 14172MFDS178-1