UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003009 |
|---|---|
| Receipt number | R000003644 |
| Scientific Title | the assessment of the inflammatory changes in abdominal aortic aneurysm by Pioglitazone |
| Date of disclosure of the study information | 2010/01/10 |
| Last modified on | 2011/07/27 09:21:41 |
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Basic information
Public title
the assessment of the inflammatory changes in abdominal aortic aneurysm by Pioglitazone
Acronym
AIC test
Scientific Title
the assessment of the inflammatory changes in abdominal aortic aneurysm by Pioglitazone
Scientific Title:Acronym
AIC test
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm, arteriosclerosis obliterans
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
he objective of this study is to assess the effect of pioglitazone on inflammatory changes in abdominal aortic aneurysms (AAA) or ASO.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hsCRP, FACS analysis of Inflammatory cells, Inflammatory Cytokine analysis, RT-PCR analysis (Adiponectin, Leptin, TNF-alpha,IL-1beta,MCP-1, PAI-1, IL-8, IL-6, Resistin, Angiotensinogen, VEGF, MMP)
Key secondary outcomes
blood examination
75g OGTT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pioglitazone 25 cases
Interventions/Control_2
statin 25cases
Interventions/Control_3
ARB 25 cases
Interventions/Control_4
non-treated 25ceses
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who agreed this study
Key exclusion criteria
1,the patients who did not agree this study
2,infective aneurysm
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu KUROBE |
Organization
IHBS, the university of TOKUSHIMA Graduate of School
Division name
Cardiovascular surgery
Zip code
Address
3-18-15 Kuramoto-chou, Tokushima
TEL
088-633-7408
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu KUROBE |
Organization
IHBS, the university of TOKUSHIMA Graduate of School
Division name
Cardiovascular surgery
Zip code
Address
3-18-15 Kuramoto-chou, Tokushima
TEL
088-633-7408
Homepage URL
hp@tokushima-cvs.info
Sponsor or person
Institute
IHBS, the university of TOKUSHIMA Graduate of School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 10 | Day |
Last modified on
| 2011 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003644
