UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026239 |
|---|---|
| Receipt number | R000029879 |
| Scientific Title | Exchange from Beraprost to Selexipag study |
| Date of disclosure of the study information | 2017/02/21 |
| Last modified on | 2023/03/16 10:25:47 |
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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
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
u1@iuhw.ac.jp
Sponsor or person
Institute
Chiba university, Graduate School of Medicine
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
