UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016875 |
|---|---|
| Receipt number | R000019587 |
| Scientific Title | The effect of azilsartan medoxomil on the variability of home blood pressure and diabetic vascular complications in patients with type 2 diabetes |
| Date of disclosure of the study information | 2015/03/23 |
| Last modified on | 2016/07/21 10:59:16 |
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Basic information
Public title
The effect of azilsartan medoxomil on the variability of home blood pressure and diabetic vascular complications in patients with type 2 diabetes
Acronym
Azilsartan and blood pressure variability in T2DM
Scientific Title
The effect of azilsartan medoxomil on the variability of home blood pressure and diabetic vascular complications in patients with type 2 diabetes
Scientific Title:Acronym
Azilsartan and blood pressure variability in T2DM
Region
| Japan |
Condition
Condition
Type 2 diabetic patients with hypertension
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether azilsartan could improve the variability of home blood pressure in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of variability in home blood pressure at 3 months after administration of azilsartan
Key secondary outcomes
The change of albuminuria at 3 months after administration of azilsartan
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from ARBs other than azilsartan to azilsartan
Interventions/Control_2
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
Type 2 diabetic patients with hypertension who are receiving ARBs other than azilsartan
Key exclusion criteria
Patients who are already taking azilsartan treatment
Patients with aliskiren
Patients with active infectious diseases, malignant diseases, severe liver dysfunction and/or renal dysfunction
Pregnant women
Patients who have difficulty in understanding the protocol of the present study such as dementia or unconsciousness
Patients whose anti-hypertensive agents were changed within 3 months prior to enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
bouchi.mem@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
bouchi.mem@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
| 2015 | Year | 03 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | 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
| 2015 | Year | 03 | Month | 23 | Day |
Last modified on
| 2016 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019587
