UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011403 |
|---|---|
| Receipt number | R000013353 |
| Scientific Title | The antihypertensive efficacy of Azilsartan on Nocturnalblood pressure by automated sphygmomanometer |
| Date of disclosure of the study information | 2013/08/07 |
| Last modified on | 2013/08/07 15:01:12 |
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Basic information
Public title
The antihypertensive efficacy of Azilsartan on Nocturnalblood pressure by automated sphygmomanometer
Acronym
The antihypertensive efficacy of Azilsartan on Nocturnalblood pressure by automated sphygmomanometer
Scientific Title
The antihypertensive efficacy of Azilsartan on Nocturnalblood pressure by automated sphygmomanometer
Scientific Title:Acronym
The antihypertensive efficacy of Azilsartan on Nocturnalblood pressure by automated sphygmomanometer
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and superiority of switching to azilsartan on nocturnal blood pressure in hypertension patients with Olmesartan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
variation of nocturnal blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
azilsaltan to olmesartan
Interventions/Control_2
azilsaltan to olmesartan
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
Outpatients
Patients who signed to participate in this clinical trial.
Hypertension patients who are taking olmesartan
Key exclusion criteria
A history of myocardial infarction within 1 week
A history of cerebrovascular disorder within 3 months
Serum Cr>2.0 mg/dL
history of hyperergia to Azilsartan and Olmesartan or similar compounds
Patients with pregnancy or with the possibility of pregnancy
Patients started taking Olmesartan within 4 weeks
Patients who changed the antihypertensive drugs most recently.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Akaishi |
Organization
Kitasato institute hospital Kitasato University
Division name
Department of cardiology
Zip code
Address
5-9-1 Shirokane Minato-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Megumi Shimada |
Organization
Kitasato institute hospital Kitasato University
Division name
Department of cardiology
Zip code
Address
TEL
Homepage URL
shimadam@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Department of cardiology Kitasato institute hospital Kitasato University
Institute
Department
Personal name
Funding Source
Organization
No
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
| 2013 | Year | 08 | Month | 07 | 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
| 2013 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | 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
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2013 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013353
| 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 |
