Reducing antihypertensive medication by Digital therapeutics in patients with essential hypertension (Reduction study)
- Conditions
- essential hypertension
- Registration Number
- JPRN-jRCT2032230512
- Lead Sponsor
- Takagi Yusuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 122
1) Patients with essential hypertension who are 20 years of age or older at the time of consent
2) Patients with an average early morning home blood pressure of less than 135/85 mmHg during the week prior to enrollment
3) Patients whose home blood pressure (both early morning and bedtime) has been measured for at least 5 days during the week prior to enrollment
4) Patients whose lifestyle modification is considered to be necessary by the investigator or subinvestigator
5) Patients who have access to a smartphone (iOS or Android) and carry it on a daily basis
6) Patients who are willing to take blood pressure measurements and enter blood pressure throughout the study period
1) Patients with secondary hypertension or suspected secondary hypertension
2) Patients with blood pressure of stage II or III hypertension at the time of initiation of drug therapy
3) Patients whose dosage and administration of the following antihypertensive drugs have been changed during the 3 months prior to obtaining consent until the second week of the treatment period (except for patients who have had a systolic blood pressure of less than 120 mmHg for 2 consecutive days since enrollment and have discontinued antihypertensive drugs before the second week of the treatment period has passed)
Calcium channel blocker
ARB
ACE inhibitor
4) Patients who are using (or will use) concomitantly prohibited drugs or concomitantly prohibited therapies during the study period
5) Patients for whom continuation of antihypertensive medication is recommended based on medical
history, comorbidities, or risk of cerebrovascular disease
6) Patients whose family members or partners are already participating in the study
7) Patients who have used the study device in the past
8) Patients who are not suitable to participate in this study for other reasons as determined by the investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of successful withdrawal at 12 weeks after initiation of treatment with the study device.
- Secondary Outcome Measures
Name Time Method