<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02244528</url>
  </required_header>
  <id_info>
    <org_study_id>14172MFDS178-1</org_study_id>
    <nct_id>NCT02244528</nct_id>
  </id_info>
  <brief_title>PK Study of Sildenafil in Neonate</brief_title>
  <official_title>Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used&#xD;
      as treatment of pulmonary hypertension in neonate and preterm infant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC(0-t)</measure>
    <time_frame>t up to 5 weeks</time_frame>
    <description>5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax(0-t)</measure>
    <time_frame>t up to 5 weeks</time_frame>
    <description>5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pulmonary arterial hypertension at 5 weeks</measure>
    <time_frame>pre, 2 weeks, 5 weeks of drug administration</time_frame>
    <description>Echocardiography&#xD;
RV systolic pressure: TR velocity2 x 4&#xD;
Septum contour: normal, flat at end-systole, flat at end-diastole&#xD;
LV shape: normal, partially D-shape, D-shape, squeezed&#xD;
LV eccentricity index&#xD;
RV area/LV area (Apical 4 chamber view, at end diastole)&#xD;
RA enlargement (Apical 4 chamber view)&#xD;
RV anterior wall thickness&#xD;
TAPSE (Tricuspid annular plane systolic excursion)&#xD;
RV Tei index (by tissue Doppler)&#xD;
Tissue Doppler velocity at RV free wall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>respiratory severity score</measure>
    <time_frame>pre, 2 weeks, 5 weeks after administration</time_frame>
    <description>Mean airway pressure x FiO2</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Neonates and Preterm Infants</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sildenafil treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sildenafil</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted at NICU in Seoul National University Hospital or Bundang Seoul National&#xD;
             University hospital&#xD;
&#xD;
          -  Infants who were diagnosed with PAH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe allergic reaction to sildenafil&#xD;
&#xD;
          -  Inotropics for hypotension within 3 days prior to enrollment&#xD;
&#xD;
          -  AST or ALT &gt; 3x ULN&#xD;
&#xD;
          -  Any condition that would make the participant, in the opinion of the investigator,&#xD;
             unsuitable for the stud&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Month</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han-Suk Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Children's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>October 13, 2017</last_update_submitted>
  <last_update_submitted_qc>October 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Han-Suk Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sildenafil Citrate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02244528
org study id: 14172MFDS178-1
nct id: NCT02244528
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC(0-t)
time frame: t up to 5 weeks
description: 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
measure: Cmax(0-t)
time frame: t up to 5 weeks
description: 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
measure: Change from baseline in pulmonary arterial hypertension at 5 weeks
time frame: pre, 2 weeks, 5 weeks of drug administration
description: 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
measure: respiratory severity score
time frame: pre, 2 weeks, 5 weeks after administration
description: Mean airway pressure x FiO2
arm group label: Treatment
arm group type: Experimental
description: sildenafil treatment
intervention type: Drug
intervention name: Sildenafil
arm group label: Treatment
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Month
healthy volunteers: No
last name: Han-Suk Kim, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Han-Suk Kim
investigator title: Professor
mesh term: Premature Birth
mesh term: Sildenafil Citrate