UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002946 |
|---|---|
| Receipt number | R000003581 |
| Scientific Title | The study comparing ezetimibe with pravastatin on expressions and activities of small GTP-binding proteins, and on endothelial function. |
| Date of disclosure of the study information | 2009/12/28 |
| Last modified on | 2010/12/30 10:22:16 |
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Basic information
Public title
The study comparing ezetimibe with pravastatin on expressions and activities of small GTP-binding proteins, and on endothelial function.
Acronym
The study comparing ezetimibe with pravastatin on expressions and activities of small GTP-binding proteins, and on endothelial function.
Scientific Title
The study comparing ezetimibe with pravastatin on expressions and activities of small GTP-binding proteins, and on endothelial function.
Scientific Title:Acronym
The study comparing ezetimibe with pravastatin on expressions and activities of small GTP-binding proteins, and on endothelial function.
Region
| Japan |
Condition
Condition
Atherosclerotic cardiovascular diseases
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effect of ezetimebe comparing with pravastatin on expressions and activities of small GTP-binding proteins, and on endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Expressions and activities of small-GTP binding proteins
FMD(flow-mediated dilation)
Key secondary outcomes
Serum total and LDL cholesterol
Serum triglyceride
Cholesterol absorption and synthesis markers
Adiponectin
High sensitive CRP
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ezetimibe(10mg/day)
Interventions/Control_2
Pravastatin(10mg/day)
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
Healthy individual
Key exclusion criteria
Pregnant or possibly pregnant individuals.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Fukumoto |
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
Department of cardiovascular medicine, Tohoku university graduate school of medicine
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
東北大学病院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 28 | 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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 28 | Day |
Last modified on
| 2010 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003581
