UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011936 |
|---|---|
| Receipt number | R000012993 |
| Scientific Title | Ehime Study - Effect of Azilsartan on Home Blood Pressure |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2020/04/06 10:25:36 |
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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
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
miyoken@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Pulmonology, Hypertension & Nephrology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012993
