UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014901 |
|---|---|
| Receipt number | R000017334 |
| Scientific Title | Effect of the Azilsartan for sleep disordered breathing with hypertension |
| Date of disclosure of the study information | 2014/09/20 |
| Last modified on | 2014/08/20 11:31:48 |
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Basic information
Public title
Effect of the Azilsartan for sleep disordered breathing with hypertension
Acronym
Effect of the Azilsartan for sleep disordered breathing with hypertension
Scientific Title
Effect of the Azilsartan for sleep disordered breathing with hypertension
Scientific Title:Acronym
Effect of the Azilsartan for sleep disordered breathing with hypertension
Region
| Japan |
Condition
Condition
Sleep disordered breathing with hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of Azilsartan on sympathetic nerve activity in sleep disordered breathing with hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effect of Azilsartan on sympathetic nerve activity in sleep disordered breathing with hypertension
Key secondary outcomes
Effect of Azilsartan on Blood Pressure in sleep disordered breathing with hypertension
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AT1 receptor blocker:Azilsaratan
Interventions/Control_2
no medication
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
sleep disordered breathing with hypertension
Key exclusion criteria
pregnancy
bilateral renal artery stenosis
hyperpottasium
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Sobue |
Organization
Fujita Health University
Division name
cardiology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake city, Aichi
TEL
0562-93-2312
sobue@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Sobue |
Organization
Fujita Health University
Division name
cardiology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake city, Aichi
TEL
0562-93-2312
Homepage URL
sobue@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
| 2014 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 20 | 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
| 2014 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017334
