UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011728
Receipt number R000013711
Scientific Title Effect of irbesartan,angiotensin 2 receptor antagonist(ARB)for urinary marker of the hypertensive patients
Date of disclosure of the study information 2013/09/12
Last modified on 2015/09/15 08:05:34

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Basic information

Public title

Effect of irbesartan,angiotensin 2 receptor antagonist(ARB)for urinary marker of the hypertensive patients

Acronym

Effect of irbesartan,angiotensin 2 receptor antagonist(ARB)for urinary marker of the hypertensive patients

Scientific Title

Effect of irbesartan,angiotensin 2 receptor antagonist(ARB)for urinary marker of the hypertensive patients

Scientific Title:Acronym

Effect of irbesartan,angiotensin 2 receptor antagonist(ARB)for urinary marker of the hypertensive patients

Region

Japan


Condition

Condition

Hypertensive patients

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Give ARB(irbesartan) to hypertensive patients;blood pressure control,urinary marker(urine protein fixed-quantity,urinary L-FABP)of the renal function disorder improvement Liver type fatty acid-binding protein,urinary NAG;N-acetyl-beta-D-glucosamidase,urinary alfa 1-MG;alfa 1-microglobulin,urinary beta 2-MG;beta 2-microglobulin),and a review deserve it in possibility og new treatment in the practical medical treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change of the marker in the urinary for 12 weeks,24weeks,and 48 weeks (urinary L-FABP,urinary NAG,urinary alfa 1-MG,urinary beta 2-MG;beta 2-microglobulin)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

When we give irbesartan 100 mg to hypertensive of the ARB or ACEI non-dosage and do not reach the aim blood pressure, we do dose increment to up to 200 mg. In the above, we gain weight and use CCB, a diuretic together appropriately when we do not reach the aim blood pressure.

Interventions/Control_2

We change it to irbesartan of the equivalent conversion dose for ARB, the ACE to hypertensive during ARB or the ACEI dosage. When we do not reach the aim blood pressure, we make dose increment to up to 200 mg. In the above, we gain weight and use CCB, a diuretic together appropriately when we do not reach the aim blood pressure.

Interventions/Control_3

When we do not reach the aim blood pressure in the hypertensive whom we did not change to irbesartan, we increase CCB, a diuretic in quantity in the above appropriately and use it together.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Hypertensive patients

Key exclusion criteria

1;the patient of a serious impaired liver function (AST or ALT exceeds 3 times of a normal value maximum)
2;The patient that there is not serum K in a normal level range
3;A patient with pregnancy and breast-feeding or these schedules, and possibility
4;The patient who has an allergy anamnesis to a trial drug
5;the patient who judged that a doctor was unsuitable

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshige Ohashi

Organization

Murakami Memorial Hospital Asahi University

Division name

Nephrology

Zip code


Address

3-23,Hashimoto-cho,Gifu city,Gifu, 500-8523,Japan

TEL

058-253-8001

Email

shogo-k@kanazawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shogo kimura

Organization

JA Chuno Kousei Hospital

Division name

Nephrology

Zip code


Address

5-1,wakakusa,seki city,gifu 501-3802,Japan

TEL

0575-22-2211

Homepage URL


Email

shogo-k@kanazawa-med.ac.jp


Sponsor or person

Institute

Murakami Memorial Hospital Asahi University

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

朝日大学附属村上記念病院(岐阜県)、JA岐阜厚生連 中濃厚生病院(岐阜県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 12 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

2013 Year 09 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 12 Day

Last modified on

2015 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013711


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name