UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033311 |
|---|---|
| Receipt number | R000037957 |
| Scientific Title | 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 | 2021/09/15 11:23:52 |
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Basic information
Public title
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
Acronym
A Randomized, Open Label, Multi-center Trial of 24-week intervention with Designated Treatment Application for Essential Hypertension
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University
Division name
Department of Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7538
kkario@jichi.ac.jp
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 | 07 | Month | 06 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/epdf/10.1111/jch.14191
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1111/jch.14191
Number of participants that the trial has enrolled
151
Results
At the primary endpoint at week 24, HERB intervention did not reduce the mean change in 24-hour SBP by ABPM compared to the control group (adjusted difference: -0.66 mmHg, p = 0.78).
Results date posted
| 2021 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 23 | Day |
Baseline Characteristics
The overall mean age was 56.8 years, 98 males and 53 females, mean weight was 71.3 kg, and BMI was 25.7. The mean abdominal circumference was 91.6 cm. Dyslipidemia was the most common complication in 67 patients (46%), diabetes in 35 (24%), cerebrovascular disease in 2, and chronic kidney disease in 11. Fifty-five percent of the patients were receiving antihypertensive medication. The mean systolic blood pressure at baseline, 24-hour ABPM, office visit, and home was 136.9 mmHg, 145.2 mmHg, and 143.9 mmHg, respectively.
Participant flow
The 151 participants were randomly divided into 77 in the intervention group and 74 in the control group. By 16 weeks, four patients in each group and one patient in each group asked to discontinue the study.
Adverse events
During the study period, forty-one AEs (43/151 [28.5%]) were occurred, and severe AEs were seen in one participant in the intervention group (unplanned admissions in different timings by hyperglycemia and cervical hernia). There was no significant difference between the groups (Intervention, 20/77 [26.0%] vs. Controls 23/74 [31.1%]). The most frequent AE was a flu-like syndrome (19/151 [12.6%]). Also, no device-related adverse events were identified through the study.
Outcome measures
Primary endpoint
Change from baseline in the mean 24-hour systolic blood pressure by ABPM at 24 weeks of treatment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 06 | 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=R000037957
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