Skip to main content
OpenTrials
Completed

NCT Number: NCT02385721

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yoon Jun Kim

Seoul, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with essential hypertension
  • Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly
  • Male and female adults aged 20 years or older
  • Voluntarily provided a written consent to participate in the study

Exclusion criteria

  • Patients with hypersensitivity to this drug or the ingredients of this drug
  • Pregnant or breast-feeding women
  • Patients on renal dialysis
  • Patients with moderate to severe hepatic impairment
  • Patients with biliary atresia
  • Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
  • Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator
  • Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)

Treatment and study plan

Primary outcomes

  1. Number of Participants Experiencing AEs or ADRs

    Time frame: up to 12 months

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

Secondary outcomes

  1. Treatment Persistence Rate of Fimasartan

    Time frame: up to 12 months

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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Mar 11, 2015
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.