UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008700 |
|---|---|
| Receipt number | R000010212 |
| Scientific Title | Efficacy and safety of treatment with new ARB Azilsartan in hypertension patients who did not show target blood pressure by other ARBs. |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2022/03/08 16:09:46 |
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Basic information
Public title
Efficacy and safety of treatment with new ARB Azilsartan in hypertension patients who did not show target blood pressure by other ARBs.
Acronym
Study of Switching to Azilsartan
Scientific Title
Efficacy and safety of treatment with new ARB Azilsartan in hypertension patients who did not show target blood pressure by other ARBs.
Scientific Title:Acronym
Study of Switching to Azilsartan
Region
| Japan |
Condition
Condition
hypertensives
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examinate efficacy and safety of treatment with new ARB Azilsartan in hypertension patients who did not show target blood pressure by other ARBs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood pressure at 0, 2, 4 and 8 weeks after starting of treatment
Key secondary outcomes
Urinary protein or albumin, Serum creatinine and eGFR, electrolytes Na/K/Cl, Cystatin C, BNP, Safety at 0, 2, 4 and 8 weeks after starting of treatment
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 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
Patients 1) 20 years-old over, the patients who have 140/90 mmHg or more. In the case of diabetes, 130/80 or more. (JSH2009)
2) Hypertensives in ARB usual dose treatment
Key exclusion criteria
1)Past medical history of hypersensitivity to azilsartan 2)Pregnant, lactating, and possibly pregnant women and those planning to become pregnant 3)Judged as ineligible by clinical investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
yasu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Suzuki |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
Chiken@juntendo.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 08 | Month | 20 | 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
| 2012 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010212
| 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 |
