Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)

Boryung Pharmaceutical Co., Ltd601 enrolled

Overview

Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.

This study is designed 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)

Study Type

OBSERVATIONAL

Enrollment

601

Conditions

Essential Hypertension

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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: 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)

Locations (1)

Yoon Jun Kim

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants Experiencing AEs or ADRs

Number of participants experiencing AEs (or ADRs) during the study

Time frame: up to 12 months

Secondary Outcomes

Treatment Persistence Rate of Fimasartan

Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study

Time frame: up to 12 months

Data from ClinicalTrials.gov

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