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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033422
Receipt No. 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 2018/07/30

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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
Email 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
Email shibasoh@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2015 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 04 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
2018 Year 07 Month 17 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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