UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018520 |
|---|---|
| Receipt number | R000021437 |
| Scientific Title | Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/08/03 18:34:12 |
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Basic information
Public title
Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension
Acronym
Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension
Scientific Title
Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym
Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension
Region
| Japan |
Condition
Condition
CTEPH (chronic thromboembolic pulmonary hypertension)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical evaluation of switching to edoxaban from warfarin on CTEPH
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Clinical worsening events during six months after switching to edoxaban from warfarin on CTEPH
Key secondary outcomes
Evaluation of clinical parameters (Hemodynamics,right heart function, systemic vascular function, oxygenation, exercise capacity, quality of life, coagulation-lysis systems) at 6 months after edoxaban on CTEPH
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initiation of once-daily Edoxaban(60mg) during 6 months after 2 days discontinuation of warfarin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)CTEPH was diagnosed with V/Q scintigraphy and/or pulmonary angiography
2)Patients under warfarin
3)Stable patients after standard theraphy for CTEPH has been completed.
4)>= 20 years old
5)Patient with a written informed consent
Key exclusion criteria
1)Patient who is scheduled for PEA and/or BPA.
2)Newly initiation of soluble guanylate cyclase stimulator
3)Recent induction of homeoxygen therapy
4)Contraindication for edoxaban
5)High risk patients of bleeding
6)Past history of alveolar hemorrhage
7)cCr<30mL/min
8)Patients who taking more than 2 antiplatelet drugs
9)pregnant/lactating woman
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakayama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address
5-2,7-chome, Kusunoki, Chuo, Kobe, Hyogo, 650-0017, Japan
TEL
078-382-5846
nakayama@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakayama |
Organization
Department of Internal Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
5-2,7-chome, Kusunoki, Chuo, Kobe, Hyogo, 650-0017, Japan
TEL
078-382-5846
Homepage URL
http://www.med.kobe-u.ac.jp/im1/index.html
nakayama@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学医学部附属病院 (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 02 | Day |
Last modified on
| 2016 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021437
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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