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Sponsored by: |
Scios R&D, Inc. |
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Information provided by: | Scios R&D, Inc. |
ClinicalTrials.gov Identifier: | NCT00338455 |
The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of nesiritide. The study will evaluate the drug's ability to prevent clinical worsening when administered as a 28-day continuous intravenous infusion in patients receiving standard care and continuous intravenous infusion of dobutamine or milrinone.
Condition | Intervention | Phase |
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Congestive Heart Failure Cardiac Transplantation Renal Failure Renal Insufficiency |
Drug: Placebo+ Standard Care + dobutamine or milrinone Drug: Natrecor+ Standard Care + dobutamine or milrinone |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Investigation of the Use of Nesiritide in Transplant-Eligible Management of Congestive Heart Failure-TMAC |
Enrollment: | 16 |
Study Start Date: | June 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Drug: Natrecor+ Standard Care + dobutamine or milrinone
28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min
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002: Placebo Comparator |
Drug: Placebo+ Standard Care + dobutamine or milrinone
28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( VP Assoc Therapeutic Area Head ) |
Study ID Numbers: | CR003649, A051, TMAC |
Study First Received: | June 16, 2006 |
Results First Received: | October 22, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00338455 |
Health Authority: | United States: Food and Drug Administration |
ultrafiltration nesiritide cardiac transplantation dialysis |
Congestive heart failure vasodilator renal insufficiency renal failure |
Natriuretic Peptide, Brain Heart Failure Renal Insufficiency Heart Diseases Urologic Diseases |
Milrinone Kidney Diseases Dobutamine Kidney Failure |
Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Cardiotonic Agents Sympathomimetics Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents |
Protective Agents Pharmacologic Actions Adrenergic Agonists Phosphodiesterase Inhibitors Natriuretic Agents Autonomic Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Peripheral Nervous System Agents |