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drugset / Trial / NCT02248961

Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension

NCT02248961 ↗

Phase 3 Completed 179 enrolled R-Pharm Boryung Pharmaceutical Co., Ltd · collabCovance · collab
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2014-05
Primary completion
2015-08
Completion
2015-08

Outcome

Missed primary endpoint

registry analysis (other test); Kanarb (Fimasartan) vs Cozaar® (Losartan); p =0.390; Mean Difference (Final Values) -0.18; Mixed Models Analysis NCT02248961 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fimasartan Small molecule 60 mg Oral
Subject Fimasartan Small molecule 120 mg Oral
Comparator Losartan Other / unclassified 50 mg —
Comparator Losartan Other / unclassified 100 mg —

Indications

hypertensive disorder