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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033311
Receipt No. R000037957
Official scientific title of the study A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension as compared with standard life-style modification therapy
Date of disclosure of the study information 2018/07/06
Last modified on 2018/07/06

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Basic information
Official scientific title of the study A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension as compared with standard life-style modification therapy
Title of the study (Brief title) A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension
Region
Japan

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

Objectives
Narrative objectives1 To investigate efficacy of treatment application for essential hypertension
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in mean 24-hour blood pressure from baseline at Week 24
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Intervention group:
Use the application in addition to standard therapy of hypertension with life-style modification
Interventions/Control_2 Control group: standard therapy of hypertension with life-style modification
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 mild to moderate essential hypertension using smartphones who are or are not under treatment of hypertension(drugs, etc.)
Key exclusion criteria Patients with severe hypertension, a history of secondary hypertension, cardiovascular / cerebrovascular events, etc.
Target sample size 140

Research contact person
Name of lead principal investigator Kazuomi Kario
Organization Jichi Medical University
Division name Department of Medicine
Address 3311-1, Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person Taeko Kikuchi
Organization CureApp, Inc.
Division name Regulatory and Clinical Affairs
Address 4th floor, 12-5, Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
TEL 03-6231-0183
Homepage URL
Email t-kikuchi@cureapp.jp

Sponsor
Institute CureApp, Inc.
Institute
Department

Funding Source
Organization CureApp, Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 07 Month 06 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 10 Month 18 Day
Anticipated trial start date
2018 Year 03 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
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037957

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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