UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002292 |
|---|---|
| Receipt number | R000002799 |
| Scientific Title | Substudy of lipid lowering trial on prevention of atherosclerosis in 75 or older on cholesterol absorption and synthesis |
| Date of disclosure of the study information | 2009/08/10 |
| Last modified on | 2015/06/02 09:59:36 |
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Basic information
Public title
Substudy of lipid lowering trial on prevention of atherosclerosis in 75 or
older on cholesterol absorption and synthesis
Acronym
EWTOPIA75-Kyushu
Scientific Title
Substudy of lipid lowering trial on prevention of atherosclerosis in 75 or
older on cholesterol absorption and synthesis
Scientific Title:Acronym
EWTOPIA75-Kyushu
Region
| Japan |
Condition
Condition
Hyper-LDL-cholesterolemia
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Endocrinology and Metabolism | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of ezetimibe on cholesterol absorption-synthesis, inflammation markers and cardiovascular events.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
0 to 24weeks
(1)changes in cholesterol absorption and synthesis
(2)changes in inflammation markers
(3)changes in lipoproteins(RLPcholesterol, small dense LDL etc),
oxydised phospholipid, oxdised cholesterol)
(4)NT-proBNP
Key secondary outcomes
relation to composite
cardiovascular events (same as EWTOPIA75)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ezetimibe and diet
Interventions/Control_2
diet
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
same as EWTOPIA75
Key exclusion criteria
same as EWTOPIA75
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Sasaki, MD,PhD |
Organization
International University of Health and Welfare
Division name
Pharmaceutical Medicine
Zip code
Address
1-3-1 Nagahama Chuoku, Fukuoka, Japan
TEL
092-711-1126
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Sasaki, MD.PhD |
Organization
EWTO75-Kyushu group
Division name
EWTOPIA-Kyushu group office
Zip code
Address
1-3-1 Nagahama Chuoo-ku, Fukuoka, Japan
TEL
092-711-1126
Homepage URL
fukuoka-shiken@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2009 | Year | 08 | Month | 10 | 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
| 2009 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 04 | Day |
Last modified on
| 2015 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002799
