N/A Completed N=601

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

Hypertension

Source: ClinicalTrials.gov NCT02385721 ↗

Enrolled (actual)

601

Serious AEs

5.5%

Results posted

Feb 2019

Primary outcomePrimary: Number of Participants Experiencing AEs or ADRs — 184; 59 Participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing AEs or ADRs	184; 59	—
SECONDARY Treatment Persistence Rate of Fimasartan	371; 230	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.