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Clinical Trial Summary

A randomized, double-blind, Multicenter, parallel, placebo-controlled study


Clinical Trial Description

The purpose of the study is to evaluate the efficacy, safety and tolerability of intravenous infusion of Levosimendan for 24hrs in patients with ADHF who will be hospitalized with ADHF and continue to have symptom of dyspnea at rest(NYHA Class III or IV) despite with treatment of SOCs(include intravenous diuretics, vasodilators and/or positive inotropic drugs but except amrinone and milrinone) within 48hrs Efficacy is measured by Clinical composite classification(Improved, No change, Worse), bio-marker(change of BNP and ST-2), Patient's Global Assessment, NYHA functional Classification, hospitalization period and renal function tests(change of creatinine, BUN and NGAL) Safety is measured by recording the incidence of adverse events(AEs), vital signs, clinical blood safety tests(biochemistry, hematology) and concomitant medications ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03555123
Study type Interventional
Source Yooyoung Pharmaceutical Co., Ltd.
Contact Lee Su-min
Phone +82-2-6202-7119
Email smlee@yypharm.co.kr
Status Recruiting
Phase Phase 3
Start date January 11, 2019
Completion date July 30, 2022

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