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Sponsored by: |
Scios R&D, Inc. |
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Information provided by: | Scios R&D, Inc. |
ClinicalTrials.gov Identifier: | NCT00271557 |
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 worsening congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels is deemed appropriate.
Condition | Intervention | Phase |
---|---|---|
Heart Failure, Congestive Heart Decompensation |
Drug: nesiritide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Active-Controlled, Multicenter Phase III Safety Study of Two Doses of NATRECOR® hBNP (Nesiritide) Administered as a Continuous Infusion in the Treatment of Decompensated CHF. |
Estimated Enrollment: | 305 |
Study Start Date: | December 1996 |
Estimated Study Completion Date: | December 1997 |
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 on the flow of blood throughout the body; the hormones secreted by the nervous system; and support of copious salt outputs by the renal system not provided by currently available therapies. The purpose of this safety study is to evaluate NATRECOR® hBNP in subjects with symptomatic, decompensated congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, IV diuretics) is deemed appropriate. This is a multi-center, randomized, open-label, safety study designed to compare two doses of NATRECOR® hBNP for the treatment of decompensated congestive heart failure. One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion. The duration of NATRECOR® hBNP therapy is determined by the attending physician. The study hypothesis is that doses of NATRECOR® hBNP in the range of 0.015 to 0.03 µg/kg/min provide an optimal safety/efficacy profile for the treatment of decompensated CHF.
One treatment group receives NATRECOR® hBNP fixed-dose infusion IV bolus of 0.3 µg/kg followed by a 0.015 µg/kg/min infusion; group two receives IV bolus of 0.6 µg/kg followed by a 0.03 µg/kg/min infusion. The duration of NATRECOR® hBNP therapy is determined by the attending physician.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR005203 |
Study First Received: | December 30, 2005 |
Last Updated: | October 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00271557 |
Health Authority: | United States: Food and Drug Administration |
Heart Failure Renal Dysfunction Cardiomyopathy Heart Decompensation Dyspnea Paroxysmal. |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Cardiomyopathies Dyspnea |
Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |