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Carperitide in Acute Respiratory Distress Syndrome (ARDS)

This study has been completed.
Sponsor:
Information provided by:
Suntory Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00030121
First received: January 31, 2002
Last updated: February 19, 2008
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Respiratory Distress Syndrome
 Drug: recombinant human atrial natriuretic polypeptide
 Phase 2

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

Further study details as provided by Suntory Pharmaceutical:

Study Start Date: December 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00030121     History of Changes
Other Study ID Numbers: SPI-001
Study First Received: January 31, 2002
Last Updated: February 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Suntory Pharmaceutical:
Acute Respiratory Distress
Acute Lung Injury

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on June 18, 2013