UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of iloprost on pulmonary hypertension and exercuse capacity
Title of the study (Brief title)	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	Shusuke Yagi
Organization	The University of Tokushima Graduate School of Health Biosciences
Division name	Department of Community Medicine and Human Resource Development
Address	3-18-15 Kuramoto-cho Tokushima-city
TEL	088-633-7851
Email	syagi@tokushima-u.ac.jp

Public contact
Name of contact person	Shusuke Yagi
Organization	The University of Tokushima Graduate School of Health Biosciences
Division name	Department of Community Medicine and Human Resource Development
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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