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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004253
Receipt No. 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

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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
Institute Endcrinology and Diabetis,Saitama Medical University
Institute
Department

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
URL(English) https://upload.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


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