Status:
COMPLETED
A Study to Develop Additional Safety and Clinical Experience With NATRECOR hBNP (Nesiritide) in the Treatment of Patients With Worsening Congestive Heart Failure Who Require Inpatient Intravenous Therapy With Medications That Influence the Tone and Caliber of Blood Vessels
Lead Sponsor:
Scios, Inc.
Conditions:
Heart Failure, Congestive
Heart Decompensation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this safety study is to evaluate NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure), in subjects with worsenin...
Detailed Description
The data from these previous studies suggest that doses of NATRECOR® hBNP may be a potent agent for the treatment of acute congestive heart failure (CHF) with a unique combination of desirable effects...
Eligibility Criteria
Inclusion
- Patients with a previous history of chronic congestive heart failure (CHF)
- presenting with symptomatic, decompensated CHF for inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, diuretics)
Exclusion
- Patients with myocardial ischemia within the past 48 hours
- having significant valvular stenosis, obstructive cardiomyopathy, constrictive pericarditis or primary pulmonary hypertension
- being treated with intravenous (IV) therapy with medications that influence the tone and caliber of blood vessels for \> 4 hours for this episode of CHF
- already being treated with IV therapy with medications that influence the tone and caliber of blood vessels that cannot be discontinued
- having cardiogenic shock, systolic blood pressure consistently \< 90 mm Hg or other significant blood circulation instability.
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1997
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00271557
Start Date
January 1 1997
End Date
December 1 1997
Last Update
March 4 2011
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