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Recruitment status Completed
Unique ID issued by UMIN UMIN000011845
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email takanori.kusuyama@nifty.ne.jp

Sponsor
Institute Department of Cardiology, Tsukazaki Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013831


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