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

Boryung

Status: Completed

Conditions: Essential Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT02385721

BR-FMS-PASS-401

Details and patient eligibility

About

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

Full description

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)

Enrollment: 601 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design