Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)
Completed
- Conditions
- Essential Hypertension
- Registration Number
- NCT02385721
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 601
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing AEs or ADRs up to 12 months Number of participants experiencing AEs (or ADRs) during the study
- Secondary Outcome Measures
Name Time Method Treatment Persistence Rate of Fimasartan up to 12 months Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study
Trial Locations
- Locations (1)
Yoon Jun Kim
🇰🇷Seoul, Korea, Republic of