N/A
N=601
Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02385721 ↗Enrolled (actual)
601
Serious AEs
5.5%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants Experiencing AEs or ADRs — 184; 59 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing AEs or ADRs |
184; 59 | — |
| SECONDARY Treatment Persistence Rate of Fimasartan |
371; 230 | — |
Summary
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02385721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.