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

Email



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/

Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name