UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018515
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email k432@sakura.med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021431

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.