UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011845 |
|---|---|
| Receipt number | R000013831 |
| Scientific Title | Effects of azilsartan compared to other angiotensin receptor blockers on left ventricular hypertrophy and the sympathetic nervous system in hemodialysis patients |
| Date of disclosure of the study information | 2013/09/24 |
| Last modified on | 2013/09/24 11:01:42 |
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Basic information
Public title
Effects of azilsartan compared to
other angiotensin receptor blockers on left ventricular hypertrophy and
the sympathetic nervous system
in hemodialysis patients
Acronym
Effects of azilsartan compared to
other angiotensin receptor blockers
Scientific Title
Effects of azilsartan compared to
other angiotensin receptor blockers on left ventricular hypertrophy and
the sympathetic nervous system
in hemodialysis patients
Scientific Title:Acronym
Effects of azilsartan compared to
other angiotensin receptor blockers
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compared the hypotensive effect, cardiac function and effect on sympathetic nervous system between azilsartan and other ARB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ambulatory blood pressure monitoring, cardiac funcion evaluated by echocardiography and serum noradrenaline at the 6-month follow-up.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
17 hypertensive patients on hemodialysis, who had been administrated ARBs, except for azilsartan, and after enrollment they were switched to azilsartan. We evaluated at baseline and at the 6-month follow-up.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients on hemodialysis who had been administrated ARBs except azilsartan for more than 6 months before enrolling this study.
Key exclusion criteria
Atrial fibrillation, poor adherence to medication, poor fluid restriction and hospitalization upon enrolling study
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Kusuyama |
Organization
Tsukazaki Hospital
Division name
Cardiology
Zip code
Address
68-1, Waku, Aboshi-ku, Himeji, Hyogo
TEL
+81-79-272-8555
takanori.kusuyama@nifty.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Kusuyama |
Organization
Tsukazaki Hospital
Division name
Cardiology
Zip code
Address
68-1, Waku, Aboshi-ku, Himeji, Hyogo
TEL
+81-79-272-8555
Homepage URL
takanori.kusuyama@nifty.ne.jp
Sponsor or person
Institute
Department of Cardiology, Tsukazaki Hospital
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
Tsukazaki Hospital(Hyogo)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 24 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 27 | 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 | 09 | Month | 24 | Day |
Last modified on
| 2013 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013831
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
