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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

601 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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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)

Conditions

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Essential Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No