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PK Study of Sildenafil in Neonate

NCT ID: NCT02244528

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neonates and Preterm Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

sildenafil treatment

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

Interventions

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Sildenafil

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Suk Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Suk Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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14172MFDS178-1

Identifier Type: -

Identifier Source: org_study_id