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Clinical trial

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

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Last updated:30th Jun 2018
Identifier: NCT03555123

Brief 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



Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation : Randomized
Intervention Model : Parallel Assignment
Masking : Double (Participant, Investigator)
Primary Purpose : Treatment
Official Title : 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
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019

Arm:
- Experimental :
SIMDAX
- Placebo Comparator : SIMDAX Placebo

Category Value
Date last updated at source 2018-06-13
Study type(s) Interventional
Expected enrolment 112
Study start date 2018-06-30
Estimated primary completion date 2019-04-30

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