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Carperitide in Acute Respiratory Distress Syndrome (ARDS) - Article


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Premenstrual Syndrome

Premenstrual Syndrome (PMS); Premenstrual Syndrome / Pms


Clinical Trial: Carperitide in Acute Respiratory Distress Syndrome (ARDS)

This study is no longer recruiting patients.

Sponsored by: Suntory Pharmaceutical
Information provided by: Suntory Pharmaceutical

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 Treatment or Intervention Phase
Respiratory Distress Syndrome
 Drug: recombinant human atrial natriuretic polypeptide
Phase II

MedlinePlus related topics:  Premature Babies;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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: 

Study start: December 1999

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 above,  Genders Eligible for Study:  Both

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

More Information

Study ID Numbers:  SPI-001
Record last reviewed:  November 2002
Last Updated:  October 13, 2004
Record first received:  January 31, 2002
ClinicalTrials.gov Identifier:  NCT00030121
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: October 3, 2005
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