UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009484 |
|---|---|
| Receipt number | R000011109 |
| Scientific Title | Investigation of new ARB effect on the function of EPCs |
| Date of disclosure of the study information | 2012/12/05 |
| Last modified on | 2012/12/05 17:53:43 |
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Basic information
Public title
Investigation of new ARB effect on the function of EPCs
Acronym
Effect of new ARB on EPCs
Scientific Title
Investigation of new ARB effect on the function of EPCs
Scientific Title:Acronym
Effect of new ARB on EPCs
Region
| Japan |
Condition
Condition
Hypertensive type two diabetes
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to investigate the efficacy of agilsaltan on EPC function of Hypertensive type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EPC vasculogenic function by EPC colony forming assay
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
New ARB aglisaltan treated group
Interventions/Control_2
Non ARB aglisaltan treated group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) systolic pressure more than 14mmHg and below 160mmHg
2) Type 2 diabetes
Key exclusion criteria
1) Patient already treated with ARB or ACE blockers
2)Patients with diabetic nephropathy
3)allergic to azirsartan
4) patients with pregnancy
5) others who physician incharge thought was inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rica Tanaka |
Organization
Juntendo University School of Medicine
Division name
Department of Plastic Surgery
Zip code
Address
2-1-1 Bunkyo-ku Hongo Tokyo Japan
TEL
0338133111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University School of Medicine
Division name
Department of Plastic Surgery
Zip code
Address
rtanaka@juntendo.ac.jp
TEL
81338133111
Homepage URL
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Funding program for Next Generation World Leading Researchers LS113
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 12 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 05 | Day |
Last modified on
| 2012 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011109
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
