UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
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 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
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


Contact us.