Unique ID issued by UMIN | UMIN000020471 |
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Receipt number | R000023533 |
Scientific Title | Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan |
Date of disclosure of the study information | 2016/01/14 |
Last modified on | 2018/03/30 12:03:41 |
Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan
Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan (MHBP trial)
Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan
Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan (MHBP trial)
Japan |
Essential Hypertension
Cardiology |
Others
NO
to compare the antihypertensive effects of olmesartan medoxomil and azilsartan in elderly hypertensive patients with home blood pressure
Efficacy
Confirmatory
Pragmatic
Not applicable
Change in morning home BP from baseline after 12 weeks
1. Change in home blood pressure variability (SD, CV)
2. Successful control rate of home blood pressure (SBP)
3. Change in home blood pressure (DBP) and pulse rate at 12 weeks
4. Change in office blood pressure(SBP, DBP) and pulse rate at 12 weeks
5. Change in pulse pressure with home and office blood pressure
Others
Home blood pressure (SBP) at 12 weeks
Safety endpoints
1. Adverse events
2. Laboratory values
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
Olmesartan group:
5to 10 mg of olmesartan medoxomil is administered in the morning once daily for 12 weeks. The dose is increased to 20 mg/day by 4 weeks.
Azilsartan group:
20 mg of azilsartan is administered in the morning once daily for 12 weeks.Use of a starting dose lower than 20 mg should be considered.
65 | years-old | <= |
Not applicable |
Male and Female
1. Age >= 65 years at the time of obtaining informed consent
2. Regardless of sex
3. Outpatients without assistance
4. Capable of measuring home blood pressure regularly and measured morning homed blood pressure within 5 days prior enrollment
5. Appropriate to add 20mg/day of olmesartan or 20mg/day of azilsartan to treated antihypertensive therapy or naive
6. Office blood pressure on the enrollment day is lower than bellow
Age from 65 to 75 years:
SBP >=140mmHg
and/or DBP >= 90mmHg
Age >= 75 years:
SBP >= 150mmHg
and/or DBP >= 90mmHg
Office blood pressure is the mean value of twice steady blood pressure values
7. Having provided written consent prior to participation in the study
1. History of hypersensitivity to test drugs
2. Secondary hypertension
3. Grade 3 hypertension (SBP >= 180mmHg and/or DBP >= 110mmHg)
4. Pregnant, possible to pregnancy, or patients who desire pregnancy
5. Taking ARB or ACE inhibitors (excluding taking these drugs more than 3 months before obtaining informed consent)
6. Taking aliskiren fumarate
7. Having serious renal dysfunction (serum creatinine >= 3.0mg/dL)
8. Having serious liver dysfunction
9. Developed cerebral hemorrhage or cerebral infarction within one year before obtaining informed consent
10. Developed myocardial infarction within one year before obtaining informed consent
11. Had a treatment of malignant tumor within 5 years before obtaining informed consent
12. undergoing hemodialysis treatment
13. Any those the investigator or other researchers consider as unsuitable
200
1st name | |
Middle name | |
Last name | Yoshikazu Fukuchi |
Daiichi-Sankyo Co., Ltd.
Medical Science Department
3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
03-6225-1042
harada.atsusi.mj@daiichisankyo.co.jp
1st name | |
Middle name | |
Last name | Makoto Arai |
Mebix, Inc.
Research Promotion Division
Akasaka Inter City, 1-11-44, Akasaka, Minato-ku, Tokyo 107-0052, Japan
03-4362-4500
mhbp@mebix.co.jp
Daiichi-Sankyo Co., Ltd.
Daiichi-Sankyo Co., Ltd.
Profit organization
Japan
NO
2016 | Year | 01 | Month | 14 | Day |
Published
Completed
2015 | Year | 12 | Month | 03 | Day |
2016 | Year | 01 | Month | 01 | Day |
2016 | Year | 12 | Month | 31 | Day |
2017 | Year | 02 | Month | 08 | Day |
2017 | Year | 02 | Month | 09 | Day |
2017 | Year | 07 | Month | 28 | Day |
2016 | Year | 01 | Month | 07 | Day |
2018 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023533
Research Plan | |
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Research case data | |
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