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

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 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


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

Value
https://center6.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