UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005973 |
|---|---|
| Receipt number | R000007068 |
| Scientific Title | Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2019/03/28 19:10:17 |
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Basic information
Public title
Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics
Acronym
Tadalafil study for pediatric PAH
Scientific Title
Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics
Scientific Title:Acronym
Tadalafil study for pediatric PAH
Region
| Japan |
Condition
Condition
pediatric pulmonary arterial hypertension
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, PAH targeted drugs have been proven to be effective for various kinds of pulmonary arterial hypertension even in padiatric population. However, dosage and manner of administration are decided after those of adults. This study aims to examine whether there might be more suitable dosage or usage for children, measuring hemodynamic indecies and drug activity.
Basic objectives2
Others
Basic objectives -Others
Plasma activity of tadalafi and hemodynamic indices, such as mean pulmonary arterial pressure or pulmonary arterial resitance, are measured sequentially after oral administration of 1mg/kg of tadalafil.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
tadalafil activity(30min, 1hr, 2hr, 3hr, 4 or 5hr) after administration
mean pulmonary arterial pressure and pulmonary arterial resistance of the same time points
Key secondary outcomes
cyclic GMP level
blood pressure, heart rate
adverse effects (headache, flushing)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
single oral administration of tadalafil 1mg/kg
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PAH
Key exclusion criteria
Those who are contraindicated for tadalafil
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu, Yamada |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pediatric Cardiology
Zip code
Address
5-7-5, Fujishiro-dai, Suita City, Osaka Prefecture, Japan
TEL
06-6833-5012
yamada.osamu.hp@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu, Yamada |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pediatric Cardiology
Zip code
Address
5-7-5, Fujishiro-dai, Suita City, Osaka Prefecture, Japan
TEL
06-6833-5012
Homepage URL
yamadao@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
国立循環器病研究センター病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007068
