UMIN-CTR Clinical Trial

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
Email	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
Email	ogawa-s@hosp.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013877