UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005105 |
|---|---|
| Receipt number | R000006060 |
| Scientific Title | The study evaluating the effects of pravastatin and atrovastatin on regulation of small GTP-binding proteins in human |
| Date of disclosure of the study information | 2011/02/21 |
| Last modified on | 2014/09/08 09:51:51 |
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Basic information
Public title
The study evaluating the effects of pravastatin and atrovastatin on regulation of small GTP-binding proteins in human
Acronym
SMG-Study
Scientific Title
The study evaluating the effects of pravastatin and atrovastatin on regulation of small GTP-binding proteins in human
Scientific Title:Acronym
SMG-Study
Region
| Japan |
Condition
Condition
Atherosclerotic cardiovascular diseases
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the differential effect of pravastatin and atrovastatin on regulation of small GTP-binding proteins
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression of SmgGDS in human leucocytes
Key secondary outcomes
1)Expressions and activities of small
GTP binding proteins
2)Serum levels of total cholesterol, LDL cholesterol, triglyceride,MDA-LDL, and RLP-C
3) Bio-markers for oxidant stress
(8-isoprostane and PTX-3)
4) Urinary cyclic GMP, 8-isoprostane, and 8-OHdG
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
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
Atrovastatin(20mg/day)
Interventions/Control_2
Pravastatin(20mg/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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individual
Key exclusion criteria
1) Pregnant or possibly pregnant individuals
2) Current smorker or history of smoking
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shiba |
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
nochioka@cardio.med.tohoku.ac.jp
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
| 2011 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23640485
Number of participants that the trial has enrolled
Results
In normal healthy volunteers, statins significantly increased SmgGDS expression with a significant negative correlation between SmgGDS expression and oxidative stress markers, whereas no correlation was noted with total or low-density lipoprotein-cholesterol.
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
| 2011 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Arterioscler Thromb Vasc Biol. 2013 Jul;33(7):1591-600.
Management information
Registered date
| 2011 | Year | 02 | Month | 18 | Day |
Last modified on
| 2014 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006060
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
