Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030121
Status:
COMPLETED
Last Update Posted:
2008-02-20
First Post:
2002-01-31
Brief Title:
Carperitide in Acute Respiratory Distress Syndrome ARDS
Sponsor:
Suntory Pharmaceutical
Organization:
Suntory Pharmaceutical
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Dose-Ranging Evaluation of the Safety and Efficacy of Carperitide Infusion in Patients With ARDS
Status:
COMPLETED
Status Verified Date:
2008-02
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 Carperitide is safe and effective in the management of Acute Respiratory Distress Syndrome ARDS
Detailed Description:
Acute respiratory distress syndrome ARDS is a severe form of acute lung injury ARDS is characterized by an increase in pulmonary vascular permeability resulting from a non-cardiogenic cause leading to an increased vascular water volume pulmonary inflammation and severe hypoxemia Conventional therapy for ARDS is primarily respiratory management by mechanical ventilation using positive end-expiratory pressure PEEP Mechanical ventilation is the major management concern in patients with ARDS due to its higher risk of infections and morbidity Treatment with Carperitide may reduce time on the ventilator by reducing pulmonary edema and by improving gas exchange The results of Carperitide studies in animals and humans support the idea that the hormone will be effective in managing the acute pulmonary complications and hypoxemia seen in ARDS
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