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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027284
Receipt No. 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

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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
Institute The University of Tokushima Graduate School of Health Biosciences
Institute
Department

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
URL(English) https://upload.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


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