UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the Effect of Anti-hypertensive Medication on Central Blood Pressure Using Home BP device
Title of the study (Brief title)	ACPhome
Region	Japan

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

Objectives
Narrative objectives1	The evaluation of the effect of anti-hypertesive medication on central blood pressure by Home BP device
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The reduction of central blood pressure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Medication
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with the indication of anti-hypertensive medication acording to JSH2009
Key exclusion criteria	allergy for medication; pregnant and its possibility; severe liver disease
Target sample size	100

Research contact person
Name of lead principal investigator	Hirofumi Tomiyama
Organization	Tokyo Medical University
Division name	The reduction of central blood pressure
Address	6-7-1 nishisinjyuku shinjyuku-ku tokyo japan
TEL
Email

Public contact
Name of contact person
Organization	Tokyo Medical University
Division name	The Second Department of Internal Medicine
Address
TEL
Homepage URL
Email	tomiyama@tokyo-med.ac.jp

Sponsor
Institute	The Second Department of Internal Medicine Tokyo Medical University
Institute
Department

Funding Source
Organization	OMRON Health Care corporation
Organization
Division
Category of Funding Organization	Other
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	東京医科大学　第二内科

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 02 Month 01 Day
Anticipated trial start date	2011 Year 07 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 05 Month 26 Day
Last modified on	2018 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006682