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 - Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan (MHBP trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020471

Enrollment

200

Registered

2016-01-14

Start date

2016-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change in morning home BP from baseline after 12 weeks	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactMakoto Arai

Mebix, Inc. Research Promotion Division

mhbp@mebix.co.jp03-4362-4500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026