UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009606 |
|---|---|
| Receipt number | R000011268 |
| Scientific Title | Japanese study with statins treatment applying a medical database for real-world evidence. |
| Date of disclosure of the study information | 2012/12/31 |
| Last modified on | 2013/07/23 11:24:57 |
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Basic information
Public title
Japanese study with statins treatment applying a medical database for real-world evidence.
Acronym
J-STREAM REAL-WORLD
Scientific Title
Japanese study with statins treatment applying a medical database for real-world evidence.
Scientific Title:Acronym
J-STREAM REAL-WORLD
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of storng statins on clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of the major adverse cardiac and cerebrovascular Events
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women who were newly prescribed rosuvastatin or atorvastatin between 2005 and 2010 were identified from the database.
Key exclusion criteria
Patients who were prescribed ≥2 statins.
Target sample size
14000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
TEL
096-344-2111
Homepage URL
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Life Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective Cohort Study
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2013 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011268
| 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 |
