67
Participants
Start Date
September 1, 2016
Primary Completion Date
December 7, 2017
Study Completion Date
December 7, 2017
Behavioral intensification
"Suggested algorithm for behavioral intensification:~* If frequency of BP measurement ≤5 in a week, send a texting message~* If frequency of BP measurement ≤3 in a week, make a telephone contact by research nurse~* Target range of home-systolic blood pressure: 110 - 135~* If rate of outlier exceeds 50% in a week (based on ≥5 measurements in a week), make a telephone contact by research nurse (applied at least 2 weeks after randomization). A call for breakthrough visit may be issued when clinically required (decided by the institutional investigator)~* If frequency of BP measurement ≥ 10 in a week and frequency of outlier = 0 in a week, send a texting message to encourage and compliment on excellent BP management"
Pharmacological intensification based on olmesartan
"* Study drug will be provided from the roll-in period.~* Step I:~ * Use olmesartan 20 mg only if mean systolic blood pressure ≤150 mm Hg during the immediate past 2 days~ * Use olmesartan 40 mg if mean systolic blood pressure \>150 during the immediate past 2 days~* Step II: olmesartan 20 mg or 40 mg + amlodipine 5 mg~* Step III: olmesartan 20 mg or 40 mg + amlodipine 10 mg~* Step IV: olmesartan 20 mg or 40 mg + amlodipine 10 mg + hydrochlorothiazide 12.5 mg~* If blood pressure profile showed high degree variability to evoke clinical concern, consider discontinuation of hydrochlorothiazide or reduction of olmesartan dose.~* Use of beta-blockers is permitted if clinically indicated.~* At each clinic visit regardless of regular or breakthrough visit, follow the pharmacological intensification rule."
Bluetooth-equipped sphygmomanometer
"* Participants will be given a wireless Bluetooth-equipped sphygmomanometer system, which is connected to the main server through the participants' own smartphone. (Identical for both intervention and control groups)~* Every blood pressure and heart rate measured will be encrypted and stored in the main server. (Identical for both intervention and control groups)"
Seoul National University Bundang Hospital, Seongnam-si
Nowon Eulji Medical Center, Eulji University, Seoul
Seoul Medical Center, Seoul
Daiichi Sankyo Korea Co., Ltd.
INDUSTRY
Seoul National University Bundang Hospital
OTHER