UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of azilsartan medoxomil on the variability of home blood pressure and diabetic vascular complications in patients with type 2 diabetes
Title of the study (Brief title)	Azilsartan and blood pressure variability in T2DM
Region	Japan

Condition
Condition	Type 2 diabetic patients with hypertension
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether azilsartan could improve the variability of home blood pressure in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of variability in home blood pressure at 3 months after administration of azilsartan
Key secondary outcomes	The change of albuminuria at 3 months after administration of azilsartan

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Switching from ARBs other than azilsartan to azilsartan
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 diabetic patients with hypertension who are receiving ARBs other than azilsartan
Key exclusion criteria	Patients who are already taking azilsartan treatment Patients with aliskiren Patients with active infectious diseases, malignant diseases, severe liver dysfunction and/or renal dysfunction Pregnant women Patients who have difficulty in understanding the protocol of the present study such as dementia or unconsciousness Patients whose anti-hypertensive agents were changed within 3 months prior to enrollment
Target sample size	100

Research contact person
Name of lead principal investigator	Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Email	bouchi.mem@tmd.ac.jp

Public contact
Name of contact person	Ryotaro Bouchi
Organization	Tokyo Medical and Dental University
Division name	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Address	1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL	03-3813-6111
Homepage URL
Email	bouchi.mem@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 03 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 23 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 23 Day
Last modified on	2016 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019587