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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032240
Receipt No. R000036763
Scientific Title Study on 24-hour Na excretion effect of sustained ARB Azilsartan and its effect on blood pressure
Date of disclosure of the study information 2018/04/16
Last modified on 2018/04/13

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Basic information
Public title Study on 24-hour Na excretion effect of sustained ARB Azilsartan and its effect on blood pressure
Acronym Study on the effect of Na excretion and blood pressure of Azilsartan
Scientific Title Study on 24-hour Na excretion effect of sustained ARB Azilsartan and its effect on blood pressure
Scientific Title:Acronym Study on the effect of Na excretion and blood pressure of Azilsartan
Region
Japan

Condition
Condition Hypertensive patients with complication of chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of 24 hours Na excretion and blood pressure on Azilsartan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urinary Na excretion rate
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention group with Azilsartan for 12days
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 (1) Patients over 20 years of age
(2) CKD patients with hypertension thought to be unnecessary for dialysis introduction during the study period
(3) Patients for whom consent is documented for participation in this study
(4) Patients who have consent to hospitalization for participation in this study
Key exclusion criteria (1) Patients who are receiving ARB, ACE inhibitors, renin inhibitors within 2 weeks
(2) Patients falling under the contraindications of Azir Sultan
(3) Patients with severe hypertension
(4) Patients with CKDstage 5 or higher
(5) patients with insulin treatment
(6) Patients who are pregnant or nursing
(7) Patients with severe liver dysfunction
(8) Patients who are judged inappropriate for the research subject by the attending physician



Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi Tamura
Organization Yokohama City University Graduate School of Medicine
Division name Department of Medical Science and Cardiorenal Medicine
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2800
Email tamukou@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Kawai
Organization Yokohama City University Graduate School of Medicine
Division name Department of Medical Science and Cardiorenal Medicine
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2800
Homepage URL
Email ykawai2017@gmail.com

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Salt Science Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2018 Year 04 Month 16 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
2018 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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
2018 Year 04 Month 13 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036763

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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