UMIN-CTR Clinical Trial

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

Japanese hypertensive patients with diabetes mellitus.

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

percentage change of vascular resiliency.

Key secondary outcomes

percentage changes of blood pressure

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tohoku University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

09

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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