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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001305
Receipt No. R000001582
Scientific Title Beneficial effects of cholesterol absorption inhibitor,ezetimibe on impaired endothelial function in patients with metabolic syndrome.
Date of disclosure of the study information 2008/09/12
Last modified on 2017/07/31

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Basic information
Public title Beneficial effects of cholesterol absorption inhibitor,ezetimibe on impaired endothelial function in patients with metabolic syndrome.
Acronym EZET-trial
Scientific Title Beneficial effects of cholesterol absorption inhibitor,ezetimibe on impaired endothelial function in patients with metabolic syndrome.
Scientific Title:Acronym EZET-trial
Region
Japan

Condition
Condition Metabolic syndrome
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effect of ezetimebe on
endothelial function in patients with metabolic syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rho-kinase activity
FMD(flow-mediated dilation)
Key secondary outcomes serum total and LDL cholesterol
serum triglyceride
cholesterol absorption marker
adiponectin
high sensitive CRP

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 not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ezetimibe 10mg daily,during the study period.
Interventions/Control_2 control
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the following criteria.
1) Patients with Metabolic syndrome who are 20 years or older and less than 80 years at the entry.
2) Serum LDL cholesterol is 120mg/dl or over and less than 180mg/dl.
3) Patients who do not receive any lipid-lowering agents.
Key exclusion criteria 1) History of drug hypersensitivity to ezetimibe.
2) History of chronic heart failure.
3) Patients who have insulin therapy.
4) Patients who have severe liver
dysfunction. Patients who have severe kidney dysfunction.
5) Patients who have secondary dyslipidemia or drug-induced dyslipidemia.
6) Pregnant or possibly pregnant patients.
7) Other patients deemed unsuitable as subjects of the study by the treating physician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Shimokawa
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai-city
TEL 022-717-7153
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Nochioka
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai-city
TEL 022-717-7153
Homepage URL
Email nochioka@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
EZET-trial group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2008 Year 09 Month 12 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 Terminated
Date of protocol fixation
2008 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 07 Day
Last modified on
2017 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001582

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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