UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009466
Receipt number R000011119
Scientific Title Research for antihypertensive prescription and office blood pressure associated home blood control in Japan, and association of orthostatic blood pressure changes with antihypertensive regimens.
Date of disclosure of the study information 2012/12/10
Last modified on 2018/08/28 15:20:38

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Basic information

Public title

Research for antihypertensive prescription and office blood pressure associated home blood control in Japan, and association of orthostatic blood pressure changes with antihypertensive regimens.

Acronym

Research for home blood pressure, orthostatic blood pressure change, and blood pressure control in Japan

Scientific Title

Research for antihypertensive prescription and office blood pressure associated home blood control in Japan, and association of orthostatic blood pressure changes with antihypertensive regimens.

Scientific Title:Acronym

Research for home blood pressure, orthostatic blood pressure change, and blood pressure control in Japan

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Research for blood pressure control associated antihypertensive prescription in Japan.
Compare with the blood pressure control rate and antihypertensive prescription studied 2002.
Research for differences between office blood pressure and home blood pressure.
Research for relation between orhtostatic blood pressure change and antihypertensive regimens, and frequency of orthostatic hypotension or hypertenstion associated age.

Basic objectives2

Others

Basic objectives -Others

Epidemiological validation of the therapeutic situation hypertension

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood pressure control in the office
Home blood pressure control
Current status of antihypertensive regimens
Orthostatic blood pressure

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Eligible participants are hypertensives or normotensives who visit clinics from 10 DEC 2012 to 10 FEB 2013 and consent to this study. Medical office staffs can be entered this study.

Key exclusion criteria

Patients who have arrhythmia, fever, diarrhea, liver cirrhosis, glaucoma, and who are receiving hemodialysis,or taking minor tranquilizers.

Target sample size

20000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Mori

Organization

Japanese Medical and Dental Practitioners for the Improvement of Medical Care

Division name

Research Department

Zip code


Address

2-5-5 Yoyogi, Shibuya-ku, Tokyo

TEL

03-3375-5121

Email

kanagawa-hok@doc-net.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name katsumata takuma

Organization

Kanagawa Association of Medical and Dental Practitioners

Division name

Department of Clinical Research

Zip code


Address

TS plaza bldg 2 F, 2-23-2, tsuruya-Cho, Kanagawa-Ku, Yokohama, Japan

TEL

045-313-2111

Homepage URL


Email

kanagawa-hok@doc-net.or.jp


Sponsor or person

Institute

Japanese Medical and Dental Practitioners for the Improvement of Medical Care

Institute

Department

Personal name



Funding Source

Organization

Japanese Medical and Dental Practitioners for the Improvement of Medical Care

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

2012 Year 12 Month 10 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

2012 Year 10 Month 02 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Epidemiological validation of the therapeutic situation hypertension


Management information

Registered date

2012 Year 12 Month 03 Day

Last modified on

2018 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011119


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name