UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003801 |
|---|---|
| Receipt number | R000004595 |
| Scientific Title | Effect of angiotension 1 receptor antagonist on acute lung injury |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2010/06/22 17:39:14 |
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Basic information
Public title
Effect of angiotension 1 receptor antagonist on acute lung injury
Acronym
Effect of angiotension 1 receptor antagonist on acute lung injury
Scientific Title
Effect of angiotension 1 receptor antagonist on acute lung injury
Scientific Title:Acronym
Effect of angiotension 1 receptor antagonist on acute lung injury
Region
| Japan |
Condition
Condition
acute lung injury
Classification by specialty
| Pneumology | Infectious disease | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Acute lung injuury (ALI) have reported to be aggravated via stimulation of angiotension 1 receptor. We will reveal the effect of the angiotensin 1 receptor antagonist on ALI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Outcome
Key secondary outcomes
Effect on P/F ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
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
FactorA(+), FactorB(+)
Interventions/Control_2
FactorA(-), FactorB(+)
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
P/F ratio<300
Key exclusion criteria
renal failure
shock
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Isotani |
Organization
Tokyo Medical and Dental University
Division name
Department of acute critical care medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5102
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Isotani |
Organization
Tokyo Medical and dental University
Division name
Department of acute critical care medicine
Zip code
Address
1-5-45Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5102
Homepage URL
http://www.tmd.ac.jp/med/accm/
isotani.accm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
東京医科歯科大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.tmd.ac.jp/med/accm/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.tmd.ac.jp/med/accm/
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
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 22 | Day |
Last modified on
| 2010 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004595
