UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020471
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

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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 or person

Institute

Daiichi-Sankyo Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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