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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000017769 |
Receipt No. | 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 |
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 |
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Condition | |||||||
Condition | Hyper-LDL-cholesterolemia
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Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 1300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020583 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |