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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002750
Receipt No. R000003346
Scientific Title Comparison of night time blood pressure fall between ARB/diuretics and ARB alone.
Date of disclosure of the study information 2010/01/01
Last modified on 2009/11/11

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Basic information
Public title Comparison of night time blood pressure fall between ARB/diuretics and ARB alone.
Acronym ARB/diuretics and night time blood pressure
Scientific Title Comparison of night time blood pressure fall between ARB/diuretics and ARB alone.
Scientific Title:Acronym ARB/diuretics and night time blood pressure
Region
Japan

Condition
Condition The subjects with unsatisfied achievement of target blood pressure with ARB
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify night time blood pressuer fall in comparison between ARB/diuretics and ARB alone.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes night time blood pressure fall
Key secondary outcomes serun Cr, BNP, HbA1c, eGFR, estimated salt intake, uric acid

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ARB/diretics and ARB alone
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Non target achievement of blood pressure goal defined by JSH2009 with candesartan 8mg.
Key exclusion criteria The subjects with diuretics and the subjects with anti-indicatin for ARB/diuretics.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Ishigami
Organization Yokohama City University Graduate School of Medicine, Department of Medical Science and Cardio-renal Medicine
Division name Department of Medical Science and Cardio-renal Medicine
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL +81-45-787-2635
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University
Division name 1.Administrative Affairs Division
Zip code
Address
TEL
Homepage URL
Email uofuslc@hotmail.com

Sponsor
Institute Yokohama City University Graduate School of Medicine, Department of Medical Science and Cardio-renal Medicine
Institute
Department

Funding Source
Organization Yokohama City 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
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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 01 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
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2009 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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