Viewing Study NCT00036062



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Last Modification Date: 2024-10-26 @ 9:07 AM
Study NCT ID: NCT00036062
Status: COMPLETED
Last Update Posted: 2006-07-19
First Post: 2002-05-07

Brief Title: A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Sponsor: Eli Lilly and Company
Organization: Eli Lilly and Company

Study Overview

Official Title: A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
Status: COMPLETED
Status Verified Date: 2006-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator andor increase the chance of survival of patients with acute lung injury
Detailed Description: Acute lung injury often develops as a result of severe infection sepsis severe injuries inhalation of foreign substances into the lungs or pneumonia The tissues and blood vessels in the lungs become inflamed and the body does not receive enough oxygen Patients with this condition are placed on a ventilator to assist with breathing

Patients entered into this study will be randomly assigned to one of two treatment groups a sivelestat group or a placebo group Once entered into the study patients are monitored for up to 6 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
H6W-MC-MCAA None None None