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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026239
Receipt No. R000029879
Scientific Title Exchange from Beraprost to Selexipag study
Date of disclosure of the study information 2017/02/21
Last modified on 2019/06/27

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Basic information
Public title Exchange from Beraprost to Selexipag study
Acronym EXCEL study
Scientific Title Exchange from Beraprost to Selexipag study
Scientific Title:Acronym EXCEL study
Region
Japan

Condition
Condition Pulmonary Arterial Hypertension
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of exchange from Beraprost to Selexipag
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of pulmonary vascular resistance
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 PAH(Nice classification group 1)
Patients with and without ERA and/or PDE5i/sGC therapy
WHO FC 2or3
6MWD of 150-450m
mPAP>=25mmHg
Patients received treatment with Beraprost for at least 3 months

Key exclusion criteria -
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Tatsumi
Organization Chiba university, Graduate School of Medicine
Division name Department of Respirology
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
TEL 043-222-7171
Email tatsumi@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Tamura
Organization International University of Health and Welfare, Mita Hospital
Division name Cardiovascular internal medicine
Zip code 108-8329
Address 1-4-3 Mita, Minato-ku Tokyo, 108-8329, JAPAN
TEL 03-3451-8121
Homepage URL
Email u1@iuhw.ac.jp

Sponsor
Institute Chiba university, Graduate School of Medicine
Institute
Department

Funding Source
Organization -
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 International University of Health and Welfare, Mita Hospital
Address 1-4-3 Mita, Minato-ku Tokyo, 108-8329, JAPAN
Tel 03-3451-8121
Email soumu-mita.hosp@iuhw.ac.jp

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 北海道大学大学、札幌医科大学、千葉大学、東京大学、慶應義塾大学、日本医科大学、杏林大学、東京女子医科大学、浜松医科大学、国立循環器病研究センター、奈良県立医科大学、神戸薬科大学、岡山医療センター、広島大学病院、九州大学病院、国際医療福祉大学三田病院

Other administrative information
Date of disclosure of the study information
2017 Year 02 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
2016 Year 10 Month 01 Day
Anticipated trial start date
2016 Year 11 Month 27 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information right heart catheterization
MLHF
6MWT
blood test
ECG
dose of PH medicines

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029879

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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