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

Essential Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385721
• Other study ID #: BR-FMS-PASS-401
• Status: Completed
• Start date: May 2013
• Est. completion date: April 2018

Study information

• Verified date: February 2019
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: April 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Locations

Country	Name	City	State
Korea, Republic of	Yoon Jun Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing AEs or ADRs	Number of participants experiencing AEs (or ADRs) during the study	up to 12 months
Secondary	Treatment Persistence Rate of Fimasartan	Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study	up to 12 months