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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002292
Receipt No. 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

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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
Email

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
Email fukuoka-shiken@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002799

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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