drugset / Trial / NCT00338455

Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC

NCT00338455 ↗

Phase 2 Terminated 16 enrolled Scios, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

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 Natrecor (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.

Timeline

Start
2006-09
Primary completion
2007-10
Completion
2007-10

Outcome

Outcome not reported

Stopped (Enrollment): “DSMC acknowledged no safety concerns with the trial, recommending that the trial be terminated due to slow enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Nesiritide Protein / enzyme biologic 0.015 ug/kg Intravenous
Background Dobutamine Small molecule — Intravenous
Background Milrinone Small molecule — Intravenous