UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001637
Receipt number R000001968
Scientific Title Influence of Olmesartan and azelnidipine on renal function during cardiac surgery
Date of disclosure of the study information 2009/01/15
Last modified on 2014/10/29 09:36:53

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Basic information

Public title

Influence of Olmesartan and azelnidipine on renal function during cardiac surgery

Acronym

Influence of Olmesartan and azelnidipine on renal function during cardiac surgery

Scientific Title

Influence of Olmesartan and azelnidipine on renal function during cardiac surgery

Scientific Title:Acronym

Influence of Olmesartan and azelnidipine on renal function during cardiac surgery

Region

Japan


Condition

Condition

myocardial infarction, angina, aortic dessection, valve disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reserch the effects of administration of Olmesartan and azelnidipine after caridac surgery in influence for renal function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

eGFR,

Key secondary outcomes

blood pressure, heart rate, renin, angiotensin-II, aldsterone


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Patient undergoing cardiac operation
Patient from whom informed consent was obtained

Key exclusion criteria

preoperative cardiogenic shock

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University School of medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

asezai.med@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University school of medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL


Email

asezai.med@gmail.com


Sponsor or person

Institute

Nihon University Itabashi Hospital

Institute

Department

Personal name



Funding Source

Organization

self funding

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


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



Other administrative information

Date of disclosure of the study information

2009 Year 01 Month 15 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

2008 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2008 Year 06 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry

2009 Year 12 Month 01 Day

Date trial data considered complete

2009 Year 12 Month 01 Day

Date analysis concluded

2009 Year 12 Month 01 Day


Other

Other related information

prospective study


Management information

Registered date

2009 Year 01 Month 15 Day

Last modified on

2014 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001968


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name