UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035079 |
|---|---|
| Receipt number | R000039994 |
| Scientific Title | A Single Arm Trial of Continuous 24-week-intervention with Designated Treatment Application for Essential Hypertension in addition to hypertension treatment in accordance with guideline |
| Date of disclosure of the study information | 2018/11/30 |
| Last modified on | 2021/09/15 11:29:10 |
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Basic information
Public title
A Single Arm Trial of Continuous 24-week-intervention with Designated Treatment Application for Essential Hypertension in addition to hypertension treatment in accordance with guideline
Acronym
A Single Arm Trial of Continuous 24-week-intervention with Designated Treatment Application for Essential Hypertension in addition to hypertension treatment in accordance with guideline
Scientific Title
A Single Arm Trial of Continuous 24-week-intervention with Designated Treatment Application for Essential Hypertension in addition to hypertension treatment in accordance with guideline
Scientific Title:Acronym
A Single Arm Trial of Continuous 24-week-intervention with Designated Treatment Application for Essential Hypertension in addition to hypertension treatment in accordance with guideline
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 systolic blood pressure from baseline at Week 16
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use the application in addition to standard therapy of hypertension with life-style modification
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 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
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohta Satake |
Organization
Nihonbashi Smart Clinic
Division name
Nihonbashi Smart Clinic
Zip code
Address
4th floor, 12-5, Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
TEL
070-1066-4404
smartclinic.jp@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taeko Kikuchi |
Organization
CureApp, Inc.
Division name
Regulatory and Clinical Affairs
Zip code
Address
4th floor, 12-5, Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
TEL
03-6231-0183
Homepage URL
t-kikuchi@cureapp.jp
Sponsor or person
Institute
CureApp, Inc.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 | 11 | Month | 30 | 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
14
Results
-
Results date posted
| 2021 | Year | 06 | Month | 07 | Day |
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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2021 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
