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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005973
Receipt No. 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

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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
Email 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
Email yamadao@hsp.ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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