UMIN-CTR Clinical Trial

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
Last 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
1st 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