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
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
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
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
