UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009248
Receipt number R000010858
Scientific Title Off balance of talent of Irbesarutan for general practitioner study
Date of disclosure of the study information 2012/12/01
Last modified on 2014/11/12 10:55:05

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Basic information

Public title

Off balance of talent of Irbesarutan for general practitioner study

Acronym

Off target study

Scientific Title

Off balance of talent of Irbesarutan for general practitioner study

Scientific Title:Acronym

Off target study

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Assessment of the effect of irbesarutan other than its antihypertensive one.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate renal function, lipid,uric acid,after 6 months.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

When the patients do not achieve blood pressure goal,irbesartan will be newly admitted to them.If they have already taken any other angiotensin 2 receptor blocker(ARB), the ARB will be changed to irbesartan.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

(1)Older than 20 y.o. and younger than 75 y.o. when informed consent was taken.
(2)Patients who gave an written informed consent.
(3)Inadequate control of BP(Patients who don not attain target BP of JSH 2009)

Key exclusion criteria

(1)Patients who have allergy of irbesartan.
(2)Patients who get pregnant or possibility of pregnant.
(3)Patients who have bil renal artery stenosis or renal artery stenosis of unilateral kidney.
(4)Dialysis patients
(5)Patients of hyperkalemia
(6)Patients of severe renal dysfunction
(7)Liver dysfunction especially biliary cirrhosis and biliary congestion.
(8)Patients who were considered inappropriate for the study by treating doctor.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromichi Suzuki

Organization

Saitama medical University

Division name

Department of Nephrology

Zip code


Address

38 Morohongo, Moroyama, Iruma-gun, Saitama

TEL

049-276-1611

Email

kiku77@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Kikuta

Organization

Saitama medical University

Division name

Department of Nephrology

Zip code


Address

38 Morohongo, Moroyama, Iruma-gun, Saitama

TEL

049-276-1611

Homepage URL


Email

Kiku77@saitama-med.ac.jp


Sponsor or person

Institute

Saitama medical University,Department of Nephrology

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


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

2012 Year 12 Month 01 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

2012 Year 08 Month 09 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 11 Month 02 Day

Last modified on

2014 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010858


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name