At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label, Randomized, Multicenter, Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan), Manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, Tablets 60/120 mg and Cozaar® (Losartan), Manufactured by MERCK SHARP & DOHME B.V., Netherlands, Tablet 50/100 mg in Adult Patients With Grade I-II Arterial Hypertension
In Brief
A Phase 3 clinical trial evaluating Fimasartan and Losartan for Arterial Hypertension. Completed, enrolled 179 participants across 13 sites.
Detailed Summary
Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablet 50/100 mg in adult patients with Grade I-II arterial hypertension in 12 weeks of therapy
Study Details
Timeline
Interventions
Starting dose of Kanarb (Fimasartan) is 60 mg, orally, once a day in the morning. The subjects will visit the clinical site every 4 weeks to measure Arterial blood pressure (ABP). The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56). If necessary, the dose of the study drug may be increased based on the assessment of patient's condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator's judgment, indicated in source documents). When possibilities are, the patient should be administrated by the study medication at the same time in the morning.
Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V., Netherlands, tablets 50/100 mg