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Sponsored by: |
Scios R&D, Inc. |
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Information provided by: | Scios R&D, Inc. |
ClinicalTrials.gov Identifier: | NCT00270400 |
The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of Natrecor® (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) versus dobutamine, during the first 24 hours of treatment of decompensated congestive heart failure (CHF).
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Drug: nesiritide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Natrecor® (Nesiritide) Versus Dobutamine Therapy for Symptomatic, Decompensated CHF: A Safety Study Using 24-Hour Holter Monitoring - The PRECEDENT Trial: Prospective, Randomized Evaluation of Cardiac Ectopy With Dobutamine or Natrecor® Therapy |
Estimated Enrollment: | 255 |
Study Start Date: | July 1998 |
Estimated Study Completion Date: | February 1999 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR005200 |
Study First Received: | December 22, 2005 |
Last Updated: | April 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00270400 |
Health Authority: | United States: Food and Drug Administration |
Heart Decompensation Renal Dysfunction Cardiomyopathy Heart Failure Dyspnea Paroxsymal. |
Natriuretic Peptide, Brain Heart Failure Heart Diseases |
Cardiomyopathies Dyspnea Dobutamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents |
Protective Agents Pharmacologic Actions Adrenergic Agonists Natriuretic Agents Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents |