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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000005973 |
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Date of registration:
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01/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics
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Scientific title:
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Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics - Tadalafil study for pediatric PAH |
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Date of first enrolment:
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2011/08/01 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007068 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Osamu, Yamada |
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Address:
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5-7-5, Fujishiro-dai, Suita City, Osaka Prefecture, Japan
Japan |
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Telephone:
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06-6833-5012 |
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Email:
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yamada.osamu.hp@ncvc.go.jp |
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Affiliation:
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National Cerebral and Cardiovascular Center Department of Pediatric Cardiology |
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Name:
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Osamu, Yamada |
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Address:
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5-7-5, Fujishiro-dai, Suita City, Osaka Prefecture, Japan
Japan |
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Telephone:
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06-6833-5012 |
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Email:
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yamadao@hsp.ncvc.go.jp |
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Affiliation:
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National Cerebral and Cardiovascular Center Department of Pediatric Cardiology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Those who are contraindicated for tadalafil
Age minimum:
Not applicable
Age maximum:
18years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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pediatric pulmonary arterial hypertension
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Intervention(s)
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single oral administration of tadalafil 1mg/kg
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Primary Outcome(s)
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tadalafil activity(30min, 1hr, 2hr, 3hr, 4 or 5hr) after administration mean pulmonary arterial pressure and pulmonary arterial resistance of the same time points
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Secondary Outcome(s)
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cyclic GMP level blood pressure, heart rate adverse effects (headache, flushing)
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Source(s) of Monetary Support
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Japan Cardiovascular Research Foundation
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Ethics review
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Status: YES
Approval date: 01/08/2011
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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31/03/2016 |
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URL:
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