NCT03555123

Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX

A Randomized, Double-blind, Multicenter, Parallel, Placebo-controlled Study l to Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX in Patients With Acutely Decompensated Heart Failure : Korea Bridging Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Yooyoung Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
DRUG	Simdax	Levosimendan2.5mg/ml

Timeline

• Start date: 2019-01-11
• Primary completion: 2022-01-30
• Completion: 2022-07-30
• First posted: 2018-06-13
• Last updated: 2021-05-11

Locations

1 site across 1 country: South Korea