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Levosimendan

Phase 3

Heart Failure, Congestive | Small molecule | Cardiovascular |Abbott Laboratories|Last Updated: Nov 20, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Levosimendan · 2 trials · 2 indications

Phase 3 2
NCT00348504Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.Acute Heart Failure
COMPLETED1,300 Analytics
NCT00048425Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.Heart Failure, Congestive
COMPLETED600 Analytics
PHASE3COMPLETED
Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure.
Acute Heart FailureUnlock trial analytics
PHASE3COMPLETED
Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
Heart Failure, CongestiveUnlock trial analytics

Study Endpoints

Primary Endpoints

All-cause mortality in the 180 days following randomization.
A clinical composite classification incorporating a Patient Global Assessment at 6 hours, 24 hours and Day 5, combined with clinical criteria for worsening heart failure through 5 days after the start of the study drug infusion.

Secondary Endpoints

All-cause mortality during the 31 days following randomization
Mean change in plasma BNP concentration from baseline to 24 hours after the start of the study drug infusion
Number of day alive and out of hospital (DAOH) during the 180 days following randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
levosimendanDRUG -
dobutamineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Written, signed and dated informed consent * Male and female patients over 18 years of age. Females of childbearing potential must have a negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal \[two years since last menstrual cycle\], surgica...

Countries:United StatesAustraliaCanadaIsrael
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Frequently asked questions about Levosimendan

What is Levosimendan used for?

Levosimendan is an investigational small molecule being developed for the treatment of heart failure, specifically congestive heart failure and acute heart failure. It is administered intravenously and is intended for patients with decompensated chronic heart failure or acute heart failure in need of inotropic support.

Who makes Levosimendan?

Levosimendan is being developed by Abbott Laboratories, a company publicly traded under the ticker symbol ABT. The drug is currently in Phase 3 clinical development for cardiovascular indications.

What phase is Levosimendan in?

Levosimendan is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, but the drug remains under investigation for the treatment of heart failure.

What clinical trials is Levosimendan in?

Levosimendan has been studied in two completed Phase 3 trials. NCT00048425 evaluated its efficacy in decompensated chronic heart failure with 600 participants. NCT00348504 compared Levosimendan to dobutamine in 1300 patients with acute heart failure. Both trials were randomized and double-blind.

Is Levosimendan the same as dobutamine?

No, Levosimendan is not the same as dobutamine. Levosimendan is an investigational drug being developed by Abbott Laboratories, while dobutamine is a separate, established inotropic agent. The two were compared head-to-head in a clinical trial for acute heart failure.