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Carperitide in Acute Respiratory Distress Syndrome (ARDS)

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00030121
Enrollment
Unknown
Registered
2002-02-01
Start date
1999-12-31
Completion date
Unknown
Last updated
2008-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress, Acute Lung Injury

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.

Interventions

DRUGrecombinant human atrial natriuretic polypeptide

Sponsors

Suntory Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026