UMIN-CTR Clinical Trial

Basic information
Public title	Ehime Study - Effect of Azilsartan on Home Blood Pressure
Acronym	E-Earth
Scientific Title	Ehime Study - Effect of Azilsartan on Home Blood Pressure
Scientific Title:Acronym	E-Earth
Region	Japan

Condition
Condition	essential hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the difference of effect on office and home blood pressure between azilsartan and amlodipine in patients with essential hypertension
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference of blood pressure lowering effect between azilsartan and amlodipine
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	To start azilsartan at 20 mg (in patients who takes ARB except for azilsartan, to change the ARB to azilsartan 20mg) To increase the dose of azilsartan to 40 mg, if the office BP at week 4 is 140/90 mmHg and over.
Interventions/Control_2	To start amlodipine at 5 mg (in patients who takes ARB except for azilsartan, to change the ARB to amlodipine 5 mg) To increase the dose of amlodipine to 10mg, if the office BP at week 4 is 140/90mmHg and over.
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	1. Outpatients with essential hypertension who take no antihypertensive drugs or standard-dose angiotensin receptor blockers except for azilsartan. 2. Patients with systolic blood pressure 140 mmHg and over or diastolic blood pressure 90 mmHg and over. 3. Patients who were informed of possible risks and benefits from participating in the research, and signed on paper(written informed consent).
Key exclusion criteria	1.Patients with hypersensitivity reaction to azilsartan. 2.Patients with hypersensitivity reaction to dihydropyridine-based compound. 3.Pregnant or nursing mothers. 4.Patients who takes antihypertensive drugs except for angiotensin receptor blockers. 5.Patients with myocardial infarction, heart failure, or stroke within 6 months. 6.Patients withserum creatinine concentration 1.2 mg/dL and over. 7.Patients with elevated liver enzymes (AST or ALT 40 IU/L and over) 8.Patients with systolic blood pressure 180 mmHg and over or diastolic blood pressure 110 mmHg and over.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Okura
Organization	Ehime University Graduate School of Medicine
Division name	Department of Cardiology, Pulmonology, Hypertension & Nephrology
Zip code	791-0295
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5303
Email	miyoken@m.ehime-u.ac.jp

Public contact
Name of contact person	1st name Takafumi Middle name Last name Okura
Organization	Ehime University Graduate School of Medicine
Division name	Department of Cardiology, Pulmonology, Hypertension & Nephrology
Zip code	791-0295
Address	Shitsukawa, Toon, Ehime
TEL	089-960-5303
Homepage URL
Email	miyoken@m.ehime-u.ac.jp

Sponsor
Institute	Department of Cardiology, Pulmonology, Hypertension & Nephrology
Institute
Department

Funding Source
Organization	Department of Cardiology, Pulmonology, Hypertension & Nephrology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board,Ehime University Hospital
Address	Shitsukawa, Toon, Ehime
Tel	089-960-5914
Email	rinri@m.ehime-u.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	愛媛大学医学部附属病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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	2013 Year 09 Month 01 Day
Date of IRB	2013 Year 05 Month 27 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date	2017 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 01 Day
Last modified on	2020 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012993

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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