UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001305 |
|---|---|
| Receipt number | 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 22:30:39 |
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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
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
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
EZET-trial group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
