UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027284
Receipt number R000031260
Scientific Title The effect of iloprost on pulmonary hypertension and exercuse capacity
Date of disclosure of the study information 2017/07/01
Last modified on 2017/05/09 15:38:01

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Basic information

Public title

The effect of iloprost on pulmonary hypertension and exercuse capacity

Acronym

Iloprost for Pulmonary Hypertension

Scientific Title

The effect of iloprost on pulmonary hypertension and exercuse capacity

Scientific Title:Acronym

Iloprost for Pulmonary Hypertension

Region

Japan


Condition

Condition

Pulmonary arterial hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

the effect of ilopost on hemodynamics and 6MD and CVD evetns

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hemodynamics and the results of 6MDW and CVD events

Key secondary outcomes

NA


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

inhale of iloprost

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

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Pulmonary arteril hypertension

Key exclusion criteria

Unstable hemodynamics

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shusuke Yagi

Organization

The University of Tokushima Graduate School of Health Biosciences

Division name

Department of Community Medicine and Human Resource Development

Zip code


Address

3-18-15 Kuramoto-cho Tokushima-city

TEL

088-633-7851

Email

syagi@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shusuke Yagi

Organization

The University of Tokushima Graduate School of Health Biosciences

Division name

Department of Community Medicine and Human Resource Development

Zip code


Address

3-18-15 Kuramoto-cho Tokushima-city

TEL

088-633-7851

Homepage URL


Email

syagi@tokushima-u.ac.jp


Sponsor or person

Institute

The University of Tokushima Graduate School of Health Biosciences

Institute

Department

Personal name



Funding Source

Organization

Self funding

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 01 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

Preinitiation

Date of protocol fixation

2017 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 09 Day

Last modified on

2017 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name