UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023105 |
|---|---|
| Receipt number | R000026535 |
| Scientific Title | Effect of Atorvaastatin for preventing for coronary artery lesion in acute Kawasaki disease |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2016/07/12 09:14:37 |
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Basic information
Public title
Effect of Atorvaastatin for preventing for coronary artery lesion in acute Kawasaki disease
Acronym
Effect of Atorvaastatin for acute Kawasaki disease
Scientific Title
Effect of Atorvaastatin for preventing for coronary artery lesion in acute Kawasaki disease
Scientific Title:Acronym
Effect of Atorvaastatin for acute Kawasaki disease
Region
| Japan | North America |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of atorvastatin for preventing coronary artery lesion in acute Kawasaki disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
coronary artery echocardiography in 1 month after therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
atrvastatin 0.5mg/kg 2 weeks
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
above 2,5 Z score of coronary artery
Key exclusion criteria
coronary artery aneurysm
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogata syohei |
Organization
Kitasato university
Division name
pedoatrics
Zip code
Address
1-15-1 kitasato minamiku sagamihara kanagawa
TEL
0427788829
ishiim@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ogata syohei |
Organization
Kitasato university
Division name
pedoatrics
Zip code
Address
1-15-1 kitasato minamiku sagamihara kanagawa
TEL
0427788829
Homepage URL
ishiim@med.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 12 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2016 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026535
