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Carperitide in Acute Respiratory Distress Syndrome (ARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030121
Recruitment Status : Completed
First Posted : February 1, 2002
Last Update Posted : February 20, 2008
Information provided by:
Suntory Pharmaceutical

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).

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: recombinant human atrial natriuretic polypeptide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


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

Layout table for additonal information Identifier: NCT00030121    
Other Study ID Numbers: SPI-001
First Posted: February 1, 2002    Key Record Dates
Last Update Posted: February 20, 2008
Last Verified: February 2008
Keywords provided by Suntory Pharmaceutical:
Acute Respiratory Distress
Acute Lung Injury
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Vasodilator Agents