UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033422 |
|---|---|
| Receipt number | R000038109 |
| Scientific Title | Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2021/03/19 23:07:11 |
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Basic information
Public title
Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Acronym
Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Scientific Title
Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Scientific Title:Acronym
Elucidation of individual difference factors in the pharmacokinetics and clinical effects of anticoagulants edoxaban and enoxasaparin
Region
| Japan |
Condition
Condition
Artificial knee replacement surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of individual differences in therapeutic effects and side effects of edoxaban and enoxaparin
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy (presence of thrombus by CT imaging)
Key secondary outcomes
Safety (with subcutaneous bleeding)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Edoxaban
Interventions/Control_2
Enoxaparin
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
undergoing knee replacement
Key exclusion criteria
Patients with a history of DVT and PTE.
Patients with diseases with abnormal coagulability.
Patient who can not obtain written informed consent.
Patients contraindicated with edoxaban or enoxaparin.
Patients taking warfarin.Other patients judged inappropriate by the attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaneko,Hironori |
Organization
Kitasato University, Kitasato Institute Hospital
Division name
Orthopedics
Zip code
Address
5-9-1 shirokane minato-ku tokyo
TEL
03-3444-6161
hiroka@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shibata,soichi |
Organization
Kitasato University, Kitasato Institute Hospital
Division name
Pharmacy
Zip code
Address
5-9-1 shirkane minato-ku tokyo
TEL
03-3444-6161
Homepage URL
shibasoh@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
北里大学北里研究所病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 30 | 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 | 04 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038109
| 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 |
