UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017769 |
|---|---|
| Receipt number | R000020583 |
| Scientific Title | Ezetimibe lipid lowering trial on cholesterol absorption-synthesis and prevention of atherrosclerosis in 75 or older with hight risk hyper LDL cholesterolemia |
| Date of disclosure of the study information | 2015/06/02 |
| Last modified on | 2015/06/02 11:14:54 |
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Basic information
Public title
Ezetimibe lipid lowering trial on cholesterol absorption-synthesis and prevention of atherrosclerosis in 75 or older with hight risk hyper LDL cholesterolemia
Acronym
KEEP(Kyushu Elderly Ezetimibe Phytosterol study)
Scientific Title
Ezetimibe lipid lowering trial on cholesterol absorption-synthesis and prevention of atherrosclerosis in 75 or older with hight risk hyper LDL cholesterolemia
Scientific Title:Acronym
KEEP(Kyushu Elderly Ezetimibe Phytosterol study)
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 and 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
(1) High-risk outpatients with hyper-LDL-cholesterolemia (serum LDL-cholesterol levels 140mg/dL) aged 75 years and older (at the time of written informed consent) of the both sexes (LDL-cholesterol levels are calculated with Friedewald Formula).
(2) At least one of the following factors
1. DM
2. Hypertension
3. Low-HDL-cholesterolemia
4. Hypertriglyceridemia
5. Current smoking
6. History of cerebral infarction
7. PAD
Key exclusion criteria
(1)Serum TG level400 mg/dL
(2) History of myocardial infarction
(3) History of PCI or CABG
(4) Angina pectoris requiring treatment
(5) Recent history of stroke(within 6 months)
(6) 1. AST100 IU/L 2. ALT100 IU/L 3. liver chirosis
(7) Serum creatinine level3.0 mg/dL
(8) Cancer
(9) Dementia
(10) Familial hyperchoresterolemia
(11) Atrial fibrillation
(12) Allergy to ezetimibe
(13) Patients participating in other clinical trials
(14) Patients inappropriate for the trial judged by investigators
Target sample size
1300
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
Department of medical treatment for health
Zip code
Address
2-4-16 Momochihama Sawaraku,Fukuoka,Japan
TEL
092-407-0434
fukuoka-shiken@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Sasaki,MD,PhD |
Organization
International University of Health and Welfare
Division name
Department of medical treatment for health
Zip code
Address
2-4-16 Momochihama Sawaraku,Fukuoka,Japan
TEL
092-407-0434
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
国際医療福祉大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 02 | 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=R000020583
| Research Plan | |
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| 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 |
