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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020471
Receipt No. 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

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Basic information
Public title Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan
Acronym Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan (MHBP trial)
Scientific Title Morning Homed Blood Pressure Trial in elderly hypertensive patients with olmesartan medoxomil compared to azilsartan
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshikazu Fukuchi
Organization Daiichi-Sankyo Co., Ltd.
Division name Medical Science Department
Zip code
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
1st name
Middle name
Last name Makoto Arai
Organization Mebix, Inc.
Division name Research Promotion Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 12 Month 03 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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