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Sivelestat

Phase 1

Respiratory Distress Syndrome, Adult | Small molecule | Respiratory |Eli Lilly and Company|Last Updated: Jul 19, 2006

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

Sivelestat · 1 trial · 2 indications

Phase 1 1
NCT00036062A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung InjuryRespiratory Distress Syndrome, Adult
COMPLETED600 Analytics
PHASE1COMPLETED
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Respiratory Distress Syndrome, AdultUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SivelestatDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites110

Inclusion Criteria * show evidence of acute lung injury * be on mechanical ventilation Exclusion Criteria * have undergone certain organ transplants * have severe underlying medical problems * be unlikely to survive * be pregnant or breast-feeding

Countries:United StatesAustraliaBelgiumCanadaNew ZealandSpain
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Frequently asked questions about Sivelestat

What is Sivelestat used for?

Sivelestat is an investigational small molecule being studied for use in adult respiratory distress syndrome and acute lung injury. It is a respiratory therapeutic area drug that was evaluated in a clinical trial for these conditions. The drug is still in clinical development and is not approved for commercial use.

Who makes Sivelestat?

Sivelestat is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company conducted a clinical trial to evaluate the drug's efficacy and safety in patients with acute lung injury.

What phase is Sivelestat in?

Sivelestat is in Phase 1 clinical development. It has completed one clinical trial, which was a randomized, double-blind study. The drug remains investigational and has not been approved by regulatory authorities for any use.

What clinical trials is Sivelestat in?

Sivelestat was studied in a completed clinical trial registered as NCT00036062, titled "A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury." The trial enrolled 600 participants and was conducted in the United States, Australia, Belgium, Canada, New Zealand, and Spain.

Is Sivelestat the same as any other drug?

Sivelestat is a distinct small molecule drug developed by Eli Lilly and Company. It is not known to be the same as any other marketed drug. Its development has focused on treating adult respiratory distress syndrome and acute lung injury.