UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002718
Receipt number R000003309
Scientific Title An open label multi facilities cooperation randomized control trial for prevention Evolution of Diabetic nephrOpathy by Olmesartan
Date of disclosure of the study information 2009/11/09
Last modified on 2010/04/16 11:54:53

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Basic information

Public title

An open label multi facilities cooperation randomized control trial for prevention Evolution of Diabetic nephrOpathy by Olmesartan

Acronym

Olmesartan prevents Evolution of Diabetic nephrOpathy(OEDO-STUDY)

Scientific Title

An open label multi facilities cooperation randomized control trial for prevention Evolution of Diabetic nephrOpathy by Olmesartan

Scientific Title:Acronym

Olmesartan prevents Evolution of Diabetic nephrOpathy(OEDO-STUDY)

Region

Japan


Condition

Condition

Hypertensive type2 diabetic patients without nephropathy

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Benefits of olmesartan treatment for prevention of diabetic nephropathy
-L-PGDS as a biomarker of diabetic nephropathy-

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

an incrase of albuminuria

Key secondary outcomes

1) number of patients with above 30mg/gCr albuminuria
2) an increase of urinary L-PGDS excretions


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

olmesartan10-40mg once a day for six months

Interventions/Control_2

amlodipine 2.5-10mg once a day for six months

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Hypertensive type2 diabetic patients without nephropathy
Outpatients aged 20 years or moreover
SBP is >= 130mgHg or DBP is >= 80mgHg
Type2 diabetes
Albuminuria is below 30mg/gCr
Untreated hypertensive patients or patients treated with CaB alone
Agreement

Key exclusion criteria

SBP >=160mgHg or DBP >=100mgHg.
Secondary hypertension
Severe hepatic dysfunction or renal damage.
Severe adverse effects with study drugs.
Severs clincal condition due to tumors et al.
Inappropriate cases based on the descision by responsible doctors .

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Uehara yoshio

Organization

Kyoritsu Women's University

Division name

Faculty of Home Economics

Zip code


Address

2-2-1 Hitotsubashi, Chiyoda, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyoritsu Women's University

Division name

Faculty of Home Economics

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Jyoto Hypertension Research Group

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

2009 Year 11 Month 09 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

Enrolling by invitation

Date of protocol fixation

2009 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date

2011 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 11 Month 05 Day

Last modified on

2010 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003309


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name