Carperitide in Acute Respiratory Distress Syndrome (ARDS)

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030121
• Other study ID #: SPI-001
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2002
• Last updated: February 19, 2008
• Start date: December 1999

Study information

• Verified date: February 2008
• Source: Suntory Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Carperitide is safe and effective in the management of Acute Respiratory Distress Syndrome (ARDS).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

In order to participate in the study, patients must:

• be 18 years or older

• have an acceptable PF ratio

• have adequate fluid volume

• be intubated less than 7 days

Exclusion:

In order to participate in the study, patients must not meet any of the following criteria:

• be moribund

• be immunocompromised

• have pneumonia (caused by Pneumocystis carinii)

• have recieved another investigational drug or device within the last 30 days

• have a Do not Resuscitate order

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• recombinant human atrial natriuretic polypeptide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suntory Pharmaceutical