UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan
Title of the study (Brief title)	Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan (MHBP trial)
Region	Japan

Condition
Condition	Essential Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to compare the antihypertensive effects of olmesartan medoxomil and azilsartan in elderly hypertensive patients with home blood pressure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in morning home BP from baseline after 12 weeks
Key secondary outcomes	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

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	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2	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.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	200

Research contact person
Name of lead principal investigator	Yoshikazu Fukuchi
Organization	Daiichi-Sankyo Co., Ltd.
Division name	Medical Science Department
Address	3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426, Japan
TEL	03-6225-1042
Email	harada.atsusi.mj@daiichisankyo.co.jp

Public contact
Name of contact person	Makoto Arai
Organization	Mebix, Inc.
Division name	Research Promotion Division
Address	Akasaka Inter City, 1-11-44, Akasaka, Minato-ku, Tokyo 107-0052, Japan
TEL	03-4362-4500
Homepage URL
Email	mhbp@mebix.co.jp

Sponsor
Institute	Daiichi-Sankyo Co., Ltd.
Institute
Department

Funding Source
Organization	Daiichi-Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 03 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 02 Month 08 Day
Date trial data considered complete	2017 Year 02 Month 09 Day
Date analysis concluded	2017 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 07 Day
Last modified on	2018 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023533