UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002718
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Jyoto Hypertension Research Group
Institute
Department

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
URL(English) https://upload.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


Contact us.