UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032240 |
|---|---|
| Receipt number | 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 18:44:07 |
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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
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
ykawai2017@gmail.com
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036763
