UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011892 |
|---|---|
| Receipt number | R000013877 |
| Scientific Title | A clinical questing examination to verify vasculo-protective effect of azilsartan treatment in the uncontrolled hypertensive patients with diabetes mellitus. |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2022/04/06 10:02:00 |
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Basic information
Public title
A clinical questing examination to verify vasculo-protective effect of azilsartan treatment in the uncontrolled hypertensive patients with diabetes mellitus.
Acronym
A clinical questing examination to verify vasculo-protective effect of azilsartan treatment in the uncontrolled hypertensive patients with diabetes mellitus.
Scientific Title
A clinical questing examination to verify vasculo-protective effect of azilsartan treatment in the uncontrolled hypertensive patients with diabetes mellitus.
Scientific Title:Acronym
A clinical questing examination to verify vasculo-protective effect of azilsartan treatment in the uncontrolled hypertensive patients with diabetes mellitus.
Region
| Japan |
Condition
Condition
Japanese hypertensive patients with diabetes mellitus.
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the vasculo-protective effects of azilsartan treatment in hypertensive patients with diabetes mellitus.
The purpose of this study was to investigate whether azilsartan more prevents the atherosclerosis than other antihypertensive treatments including other ARBs treatments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
percentage change of vascular resiliency.
Key secondary outcomes
percentage changes of blood pressure
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
This study is a clinical questing trial. The entry period of this study is one years. Study subjects are uncontrolled hypertensive patients with Diabetes. (If the patients have already been treating with the other ARBs, the physician in charge is able to change the ARBs to azilsartan) These patients are administered with 20 mg/day of azilsartan. The dose of azilsartan can be properly increased to 40 mg/day when the anti-hypertensive effect is insufficient.Their vascular resiliency of carotid artery and blood pressure are determined before (baseline) and after the treatment for four months.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects enrolled in the present study are hypertensive out-patients with diabetes, who fulfill the following criteria; 1) Mild or moderate hypertension defined as the blood pressure from 130 / 80mmHg to 180 / 110 mmHg. 2) Do not taking of direct renin inhibitor such as aliskiren, for at least six months. 3) The participation agreement of this study is obtained.
Key exclusion criteria
1) Corresponding to the GFR < 30 ml/min/1.73m2, or receiving continuous dialysis. 2) Woman who has pregnancy or possibility of pregnancy and suckling. 3) To have other serious and active diseases such as severe hyperglycemia (HbA1c > 10%), liver dysfunction, cardiovascular disease, malignancies and so on). 4) Severe hypertensive subjects (> 180 / 110 mmHg). 5) The patient that corresponds to taking of Aliskiren treatment. 6) The patient with renal artery stenosis, 7) The patient whose serum potassium level is more than 5.5, 8) Patient from whom physician in charge of treatment judged this study participation to be improper.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Hypertension
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7163
ogawa-s@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Hypertension
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7163
Homepage URL
ogawa-s@hosp.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University 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
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
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
| 2013 | Year | 09 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | 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 | 27 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013877
