Carperitide in Acute Respiratory Distress Syndrome (ARDS) - Tabular View

Tracking Information
First Received Date ^ICMJE	January 31, 2002
Last Updated Date	February 19, 2008
Start Date ^ICMJE	December 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00030121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Carperitide in Acute Respiratory Distress Syndrome (ARDS)
Official Title ^ICMJE	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
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Respiratory Distress Syndrome
Intervention ^ICMJE	Drug: recombinant human atrial natriuretic polypeptide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00030121
Responsible Party
Study ID Numbers ^ICMJE	SPI-001
Study Sponsor ^ICMJE	Suntory Pharmaceutical
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Suntory Pharmaceutical
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP