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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005655
Receipt No. R000006682
Scientific Title Assessment of the Effect of Anti-hypertensive Medication on Central Blood Pressure Using Home BP device
Date of disclosure of the study information 2011/07/01
Last modified on 2018/06/03

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Basic information
Public title Assessment of the Effect of Anti-hypertensive Medication on Central Blood Pressure Using Home BP device
Acronym ACPhome
Scientific Title Assessment of the Effect of Anti-hypertensive Medication on Central Blood Pressure Using Home BP device
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirofumi Tomiyama
Organization Tokyo Medical University
Division name The reduction of central blood pressure
Zip code
Address 6-7-1 nishisinjyuku shinjyuku-ku tokyo japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Medical University
Division name The Second Department of Internal Medicine
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2011 Year 02 Month 01 Day
Date of IRB
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

Other
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

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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