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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000011936 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | essential hypertension | |
Classification by specialty |
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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 |
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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. |
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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. |
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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 |
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Age-upper limit |
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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). |
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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. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |