A Multi-center, Open, Longitudinal, Observational Study to Assess the Treatment Trend and the Proportion of Target BP Attainment in Patients Whose Antihypertensive Regimens Are Changed to ARB-based Therapy
Conditions: Essential Hypertension
Sponsor: Boryung Pharmaceutical Co., Ltd

Protocol No.: BR-FMS-OS-404 
Version 1.2, 2018.12.18 
▣ Protocol Synopsis 
Study Title 
A multi-center, open, longitudinal, observational study to assess the treatment trend and the 
proportion of target blood pressure attainment in patients whose antihypertensive regimens are 
changed to angiotensin II receptor blocker-based therapy 
Study Short Title: FRESH study_FimasaRtan-basEd BP Targets after Drug SwitcHing 
Sponsor 
Boryung Pharmaceutical Co., Ltd. 
Study Objectives 
The recent hypertension clinical practice guidelines published by American College of 
Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 
mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, 
studies in Koreans must be preceded before applying such new overseas guidelines; thus, this 
study has been designed to establish clinical materials reflecting treatment setting in Korea. In 
this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed 
to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be 
followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease. 
Sample Size 
Approximately 5,000 subjects 
Subject 
Inclusion Criteria 
① Provided written consent to the use of personal information after receiving the explanation 
of the objective, methodology, etc. of this clinical study 
② Male or female adults ≥ 19 years who are diagnosed with essential hypertension 
③ Receiving outpatient treatment at the time of study enrollment 
④ Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) 
whose antihypertensive regimens decided and scheduled to be changed to ARB 
monotherapy or ARB-containing combination therapy (the result of the arm with a higher 
mean BP [systolic BP preferred] when measured twice with at least a 2-minute interval in 
both arms at the medical office on the study enrollment date, will become the reference) 
 
Definition of uncontrolled hypertension: Target BP (SBP <140 mmHg and DBP <90 
mmHg) not achieved even after the treatment using the existing antihypertensive drugs 
for 4 weeks or longer 
Subject 
Exclusion Criteria 
① Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after 
the study enrollment date 
② Patients with suspected or confirmed secondary hypertension 
③ Pregnant or breast-feeding women 
④ Patients who received investigational product within 12 weeks or are scheduled to 
participate in another clinical study while participating in this study 
⑤ Patients who are determined inappropriate for participating in the study by investigators for 
other reasons 
Statistical Analysis 
Methods 
Analysis of Primary Endpoints 
Frequency and proportion of patients who attain the target BP at Week 12 after the 
treatment regimen change will be calculated and the 95% confidence interval for the 

Protocol No.: BR-FMS-OS-404 
Version 1.2, 2018.12.18 
proportion will be provided. 
 
Analysis of Safety Data 
・ Incidence and characteristics of antihypertensive drug related adverse drug reactions 
For adverse drug reactions (ADRs) related to antihypertensive drugs, the number of 
subjects, incidence, 95% confidence interval for the incidence, and number of cases will 
be provided.  
・ Serious adverse events/adverse drug reactions 
For serious adverse events and serious adverse drug reactions, the number of subjects, 
incidence, 95% confidence interval for the incidence, and number of cases will be 
provided.