UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for antihypertensive prescription and office blood pressure associated home blood control in Japan, and association of orthostatic blood pressure changes with antihypertensive regimens.
Title of the study (Brief title)	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	Hisao Mori
Organization	Japanese Medical and Dental Practitioners for the Improvement of Medical Care
Division name	Research Department
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	katsumata takuma
Organization	Kanagawa Association of Medical and Dental Practitioners
Division name	Department of Clinical Research
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
Institute	Japanese Medical and Dental Practitioners for the Improvement of Medical Care
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011119