UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018515 |
|---|---|
| Receipt number | R000021431 |
| Scientific Title | Evaluation of the therapeutic effect of edoxaban in VTE patients |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2019/02/03 20:00:28 |
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Basic information
Public title
Evaluation of the therapeutic effect of edoxaban in VTE patients
Acronym
Evaluation of the therapeutic effect of edoxaban in VTE patients
Scientific Title
Evaluation of the therapeutic effect of edoxaban in VTE patients
Scientific Title:Acronym
Evaluation of the therapeutic effect of edoxaban in VTE patients
Region
| Japan |
Condition
Condition
venous thromboembolism
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
investigate or establish the safety and effectiveness of LIXIANAffor VTE patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
regression of the thombus after 3 months of treatment are evaluated using ultrasonography or CT
Key secondary outcomes
Anemia and influence to the kidney function before and after therapy are evaluated by blood test
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who participated in medical examination and treatment using edoxaban in our hospital
Key exclusion criteria
The person bleeding at present
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shimizu |
Organization
Toho University Sakura Medical Center
Division name
Internal medicine cardiology division
Zip code
Address
564-1 Shimosizu Sakura Chibaken Japan
TEL
+81-43-462-8811
k432@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shimizu |
Organization
Toho University Sakura Medical Center
Division name
Internal medicinae cardiology division
Zip code
Address
564-1 Shimosizu Sakura Chibaken Japan
TEL
+81-43-462-8811
Homepage URL
k432@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
TOHO University Sakura medical center cardiology division
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
東邦大学医療センター佐倉病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | 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
A thrombus of VTE was
significantly reduced by 3 months theray using edoxaban.
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 01 | Day |
Last modified on
| 2019 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021431
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
