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Sponsored by: |
Scios R&D, Inc. |
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Information provided by: | Scios R&D, Inc. |
ClinicalTrials.gov Identifier: | NCT00270387 |
The purpose of this pilot study is to compare the clinical effects, safety profile, and economic impact of standard therapy plus Natrecor® (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to standard therapy plus placebo in patients who present to the Emergency Department with worsening congestive heart failure (CHF) and are treated in the Emergency Department /Observation Unit.
Condition | Intervention | Phase |
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Heart Failure, Congestive Cardiomyopathies Dyspnea, Paroxysma |
Drug: Natrecor® [nesiritide] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated Initially in Outpatients With Natrecor® (Nesiritide) - The PROACTION Trial |
Estimated Enrollment: | 250 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | January 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR005209 |
Study First Received: | December 22, 2005 |
Last Updated: | April 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00270387 |
Health Authority: | United States: Food and Drug Administration |
Acutely Decompensated Congestive Heart Failure Kidney Failure Renal Impairment Heart Failure Myocardial Infarction. |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Infarction |
Cardiomyopathies Myocardial Infarction Dyspnea Kidney Failure |
Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |