UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009515 |
|---|---|
| Receipt number | R000011178 |
| Scientific Title | Antihypertensive effects of low-dose azilsartan in clinical practice |
| Date of disclosure of the study information | 2012/12/31 |
| Last modified on | 2014/03/13 22:26:55 |
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Basic information
Public title
Antihypertensive effects of low-dose azilsartan in clinical practice
Acronym
Antihypertensive effects of azilsartan
Scientific Title
Antihypertensive effects of low-dose azilsartan in clinical practice
Scientific Title:Acronym
Antihypertensive effects of azilsartan
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare antihypertensive effects between 10-mg/day azilsartan and 8-mg/day candesartan in Japanese patients with hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood pressure
Key secondary outcomes
albuminurea in patients with diabetes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
10 mg per day of azilsartan
Interventions/Control_2
8 mg per day of candesartan
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese patients who are treated with 8 mg per day of candesartan for hypertension
Key exclusion criteria
- patients who have been hypersensitive to candesartan or azilsartan
- pregnant women and women suspected of being pregnant
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Shiraiwa |
Organization
Shiraiwa Medical Clinic
Division name
Shiraiwa Medical Clinic
Zip code
Address
Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shiraiwa Medical Clinic
Division name
Shiraiwa Medical Clinic
Zip code
Address
TEL
Homepage URL
http://shiraiwa-medical-clinic.or.jp
Sponsor or person
Institute
Shiraiwa Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
Shiraiwa Medical Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Metabolic Medicine, Osaka University Graduate School of Medicine
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 | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
| 2012 | Year | 12 | Month | 10 | Day |
Last modified on
| 2014 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011178
