UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013317 |
|---|---|
| Receipt number | R000015536 |
| Scientific Title | Effect of tadarafil for persistant pulmonary hypertension early after congenital heart surgery in children |
| Date of disclosure of the study information | 2014/03/03 |
| Last modified on | 2017/03/11 12:29:25 |
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Basic information
Public title
Effect of tadarafil for persistant pulmonary hypertension early after congenital heart surgery in children
Acronym
Effect of tadarafil for PH early after CHD surgery
Scientific Title
Effect of tadarafil for persistant pulmonary hypertension early after congenital heart surgery in children
Scientific Title:Acronym
Effect of tadarafil for PH early after CHD surgery
Region
| Japan |
Condition
Condition
congenital heart disease associated with pulmonary hypertension after open heart surgery
Classification by specialty
| Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to validate efficacy and safety of tadarafil for persistent pulmonary hypertension early after open heart surgery in children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood pressure, heart rate, pulmonary artery pressure, SpO2, blood concentration of tadarafil (before administration, 2,4,6,8,12,16,20,24 hours after administration)
Key secondary outcomes
presence or absence of adverse event of tadarafil
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For intubated children with pulmonary hypertension after open heart surgery,0.5mg/kg of tadarafil will be administered orally, and same dose of tadarafil will be added 12 hours after initial administration.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
children younger than 16 years old with persistent pulmonary hypertension early after open heart surgery
Key exclusion criteria
case who is administered other drugs for pulmonary hypertension
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tamai |
Organization
Osaka Medical College
Division name
Department of Pediatrics
Zip code
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
ped001@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Katayama |
Organization
Osaka Medical College
Division name
Department of Pediatrics
Zip code
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
ped100@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 03 | Day |
Last modified on
| 2017 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015536
