A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and Older Diagnosed With Essential Hypertension
Conditions: Essential Hypertension
Sponsor: Boryung Pharmaceutical Co., Ltd

 
 
CONFIDENTIAL 
 
BR-FMS-PASS-401_Protocol Version 6.1 (22Nov2016)  
 
Page 1 of 1 
SYNOPSIS 
Protocol No. 
BR-FMS-PASS-401 
Sponsor 
Boryung Pharmaceutical Co., Ltd. 
Active Ingredient 
Name 
Fimasartan potassium trihydrate 
Study Title 
A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on 
Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and 
Older Diagnosed With Essential Hypertension 
Study Objectives 
Primary Objective:  
To evaluate the incidence and characteristics (profile, relationship to the study drug, 
severity, and outcome) of adverse events (AEs) observed during 1-year treatment with 
Kanarb tablet® (fimasartan) 
Secondary Objectives: 
To investigate the rates of discontinuation and persistence of 1-year treatment with Kanarb 
tablet® (fimasartan) (including the investigation of the rates of switching to other drugs 
and concomitant administration with other antihypertensive drugs) 
No. of Subject 
Target number of subjects: 600 subjects 
Inclusion Criteria 
1. 
Patients with essential hypertension 
2. 
Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or 
newly 
3. 
Male and female adults aged 20 years or older 
4. 
Voluntarily provided a written consent to participate in the study 
Exclusion Criteria Meeting any of the following including contraindications for fimasartan 
1. 
Patients with hypersensitivity to this drug or the ingredients of this drug 
2. 
Pregnant or breast-feeding women 
3. 
Patients on renal dialysis 
4. 
Patients with moderate to severe hepatic impairment 
5. 
Patients with biliary atresia 
6. 
Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-
galactose malabsorption 
7. 
Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by  
investigator 
8. 
Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal 
(ULN); TB ≥1.5 ULN) 
Statistical 
Analysis Method 
Incidence of adverse events (AEs), treatment persistence rate and treatment 
discontinuation rate of fimasartan were reported for each measurement time point and their 
95% confidence intervals were presented