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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024871
Receipt No. R000028625
Scientific Title Investigation for the effect of riociguat on right ventricular function
Date of disclosure of the study information 2016/11/21
Last modified on 2016/11/17

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Basic information
Public title Investigation for the effect of riociguat on right ventricular function
Acronym Investigation for the effect of riociguat on right ventricular function
Scientific Title Investigation for the effect of riociguat on right ventricular function
Scientific Title:Acronym Investigation for the effect of riociguat on right ventricular function
Region
Japan

Condition
Condition Pulmonary hypertension
Classification by specialty
Medicine in general Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the effect of riociguat on right ventricular function in patients with pulmonary hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes right ventricular longitudinal strain before and after riociguat administration
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Age >= 18 years
2) Inoperable patients with CTEPH or PAH, patients with recurrent PH after operation
3) patient who underwent echocardiography before and after riociguat administration
Key exclusion criteria 1) Patients without appropriate images due to the technical difficulty
2) Patients who got other drugs or underwent BPA before dose stable period
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsushige Murata
Organization Keio University, School of Medicine
Division name Department of Laboratory Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Email muratam@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsushige Murata
Organization Keio University, School of Medicine
Division name Department of Laboratory Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email muratam@keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 11 Month 21 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
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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 six minute walking distance
Borg index
WHO classification
right heart catheterization
echoacrdiography

Management information
Registered date
2016 Year 11 Month 17 Day
Last modified on
2016 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028625

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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