UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001058 |
|---|---|
| Receipt number | R000001279 |
| Scientific Title | Study of SNPs effect of Cytochrome P450 and Vitamine K related enzyme on PK/PD of warfarine |
| Date of disclosure of the study information | 2008/02/28 |
| Last modified on | 2012/03/28 09:37:51 |
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Basic information
Public title
Study of SNPs effect of Cytochrome P450 and Vitamine K related enzyme on PK/PD of warfarine
Acronym
VK-SNPs-W
Scientific Title
Study of SNPs effect of Cytochrome P450 and Vitamine K related enzyme on PK/PD of warfarine
Scientific Title:Acronym
VK-SNPs-W
Region
| Japan |
Condition
Condition
atrial fibrillarion, pulmonary embolism, deep vein thronbosis, heart failure, stroke and other cardiovascular diseases
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Geriatrics | Vascular surgery |
| Neurosurgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the detailed relation between Vitamin K related enzyme SNPs and warfarine PK/PD by simultaneous vitamin K concentration measurement in the blood.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the difference between four groups defined by SNPs of P450 and vitamin K related enzyme with PK/PD of warfarin and vitamin K concentration in the blood.
Key secondary outcomes
To evaluate the difference between four groups defined by SNPs of P450 and vitamin K related enzyme with retrospectively collected warfarin PD data as long term therapy.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
those who treated by warfarin for a long term more than 6 months, and having underwent PT-INR evaluation for more than 6 time in this period
Key exclusion criteria
None.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Matsumoto |
Organization
St. Marianna University School of Medicine
Division name
Department of Pharmacology
Zip code
Address
2-16-1 Sugao, Miyamae-ward, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Matsumoto |
Organization
St. Marianna University School of Medicine
Division name
Department of Pharmacology
Zip code
Address
2-16-1 Sugao, Miyamae-ward, Kawasaki, 216-8511 Japan
TEL
044-977-8111
Homepage URL
matsumoto@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
RIKEN Yokohama Institute
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
聖マリアンナ医科大学病院、聖マリアンナ医科大学
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment and blood drawing of patient from St. Marianna University Hospital have reached 159, and from Yokohama Seibu Hospital 96. Recruitment ended with these numbers, though the total number did not reach the scheduled 300 cases, because no more patients would be expected. Blood test and measurement are being carried out without any trouble. Analysis will be performed after the clinical information of these patients have been collected.
Management information
Registered date
| 2008 | Year | 02 | Month | 28 | Day |
Last modified on
| 2012 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
