UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of treatment with new ARB Azilsartan in hypertension patients who did not show target blood pressure by other ARBs.
Acronym	Study of Switching to Azilsartan
Scientific Title	Efficacy and safety of treatment with new ARB Azilsartan in hypertension patients who did not show target blood pressure by other ARBs.
Scientific Title:Acronym	Study of Switching to Azilsartan
Region	Japan

Condition
Condition	hypertensives
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examinate efficacy and safety of treatment with new ARB Azilsartan in hypertension patients who did not show target blood pressure by other ARBs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	blood pressure at 0, 2, 4 and 8 weeks after starting of treatment
Key secondary outcomes	Urinary protein or albumin, Serum creatinine and eGFR, electrolytes Na/K/Cl, Cystatin C, BNP, Safety at 0, 2, 4 and 8 weeks after starting of treatment

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 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients 1) 20 years-old over, the patients who have 140/90 mmHg or more. In the case of diabetes, 130/80 or more. (JSH2009) 2) Hypertensives in ARB usual dose treatment
Key exclusion criteria	1)Past medical history of hypersensitivity to azilsartan 2)Pregnant, lactating, and possibly pregnant women and those planning to become pregnant 3)Judged as ineligible by clinical investigators
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiko Tomino
Organization	Juntendo University Faculty of Medicine
Division name	Department of Internal Medicine, Division of Nephrology
Zip code
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	0338133111
Email	yasu@juntendo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Suzuki
Organization	Juntendo University Faculty of Medicine
Division name	Department of Internal Medicine, Division of Nephrology
Zip code
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	Chiken@juntendo.ac.jp

Sponsor
Institute	Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
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
Address
Tel
Email

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	2012 Year 08 Month 20 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	Completed
Date of protocol fixation	2012 Year 07 Month 10 Day
Date of IRB	2012 Year 07 Month 27 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2014 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 16 Day
Last modified on	2022 Year 03 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010212