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

NCT00338455 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-12-08

Study results available
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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.

Conditions

  • Congestive Heart Failure
  • Cardiac Transplantation
  • Renal Insufficiency
  • Renal Failure

Interventions

DRUG

Natrecor (nesiritide)+Standard Care+dobutamine or milrinone

3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min

DRUG

Placebo+Standard Care+dobutamine or milrinone

28-day continuous infusion, no bolus

Sponsors & Collaborators

  • Scios, Inc.

    lead INDUSTRY

Principal Investigators

  • Scios, Inc. Clinical Trial · Scios, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338455 on ClinicalTrials.gov