NCT02244528

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

September 11, 2014

Last Update Submit

October 13, 2017

Conditions

Neonates and Preterm Infants

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change from baseline in pulmonary arterial hypertension at 5 weeks

    pre, 2 weeks, 5 weeks of drug administration

  • respiratory severity score

    pre, 2 weeks, 5 weeks after administration

Study Arms (1)

Treatment

EXPERIMENTAL

sildenafil treatment

Drug: Sildenafil

Interventions

SildenafilDRUG
Treatment

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
  • Infants who were diagnosed with PAH

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Sildenafil Citrate

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Han-Suk Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 19, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

KR(2)