UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006241 |
|---|---|
| Receipt number | R000007336 |
| Scientific Title | Analysis of factors and individual differences in clinical efficacy and pharmacokinetics of enoxaparin,fondaparinux. |
| Date of disclosure of the study information | 2011/08/28 |
| Last modified on | 2018/07/17 20:10:10 |
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Basic information
Public title
Analysis of factors and individual differences in clinical efficacy and pharmacokinetics of enoxaparin,fondaparinux.
Acronym
Analysis of factors and individual differences in clinical efficacy and pharmacokinetics of enoxaparin,fondaparinux.
Scientific Title
Analysis of factors and individual differences in clinical efficacy and pharmacokinetics of enoxaparin,fondaparinux.
Scientific Title:Acronym
Analysis of factors and individual differences in clinical efficacy and pharmacokinetics of enoxaparin,fondaparinux.
Region
| Japan |
Condition
Condition
knee replacement surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of factors could explain the adverse effects of individual differences in the treatment of fondaparinux and enoxaparin anticoagulant,further to examine the usefulness of coagulation markers for the diagnosis of thrombos.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effectiveness and relevance of pharmacokinetics and safety.
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fondaparinux
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
| Not applicable |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing knee replacement surgery
Key exclusion criteria
under twenty years.
with a history of DVT and PTE.
With the disease have abnormal clotting.
Patient's written consent not obtained.
contraindications to enoxaparin or fondaparinux.
The patient has been administered warfarin.
Patients with other treating physician deems inappropriate.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Tsukimura |
Organization
Kitasato university, Kitasato institute hospital
Division name
orthopedics
Zip code
Address
5-9-1 shirokane minato-ku tokyo japan
TEL
03-3444-6161
tsukky@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shibata soichi |
Organization
Pharmacy
Division name
Pharmacy
Zip code
Address
5-9-1 shirokane minato-ku tokyo japan
TEL
03-3444-6161
Homepage URL
shibasoh@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university, Kitasato institute hospital,department of orthopedics
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 28 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | 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
| 2011 | Year | 08 | Month | 28 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007336
