UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004253
Receipt number R000005107
Scientific Title Comparison of hypotensive effect and prevention to progression of diabetic nephrolopathy with Olmesartan and Ca channel blocker in patient of type 2 diabetic
Date of disclosure of the study information 2010/09/22
Last modified on 2019/04/22 10:20:51

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Basic information

Public title

Comparison of hypotensive effect and prevention to progression of diabetic nephrolopathy with Olmesartan and Ca channel blocker in patient of type 2 diabetic

Acronym

Saitama Olmesartan Randomised Trial(SORT study)

Scientific Title

Comparison of hypotensive effect and prevention to progression of diabetic nephrolopathy with Olmesartan and Ca channel blocker in patient of type 2 diabetic

Scientific Title:Acronym

Saitama Olmesartan Randomised Trial(SORT study)

Region

Japan


Condition

Condition

hypertension with type 2 diabetis

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of hypotensive effect and prevention to progression of diabetic nepropathy with Olmesartan and Ca channnel blocker

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Office blood pressure , Albumin-Creatinin Ratio , Serum-Creatinin Consentration

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of Olmesartan 40mg

Interventions/Control_2

administration of Olmesartan 20mg with Amlodipine 5mg or

Interventions/Control_3

administration of Olmesartan 20mg with Azernidipne 16mg

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

1)Olmesartan naive patient
2)SBP over130mmHg and/or DBP over80mmHg
3)ACR over30mg/gCr and/or S-Cr over1.0

Key exclusion criteria

patient of
1)RAS inhibitor with Ca channel Blocker
2)except from 20 to 80 years old
3)SBP less than 130mmHg or DBP less than 80mmHg
4)HbA1c over 8.0%
5)S-Cr over 2.5mg/dL
6)hypersensitivity to drug in object
7)inadequate with Doctor's decision

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sigehiro Katayama

Organization

Saitama Medical University

Division name

Endcrinology and Diabetis

Zip code


Address

38 Morohongo, Moroyama-machi,Iruma-gun,Saitama,Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Saitama Medical University

Division name

Endcrinology and Diabetis

Zip code


Address


TEL

0492-76-1204

Homepage URL


Email

ynoguchi@saitama-med.ac.jp


Sponsor or person

Institute

Endcrinology and Diabetis,Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Endcrinology and Diabetis,Saitama Medical University

Organization

Division

Category of Funding Organization

Other

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

2010 Year 09 Month 22 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

Terminated

Date of protocol fixation

2010 Year 07 Month 01 Day

Date of IRB

2010 Year 06 Month 12 Day

Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2013 Year 09 Month 30 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2014 Year 03 Month 31 Day

Date analysis concluded

2014 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 22 Day

Last modified on

2019 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005107


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name