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A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

NCT00475852 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7141

Last updated 2013-03-08

Study results available
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Summary

The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

Conditions

  • Heart Decompensation

Interventions

DRUG

Nesiritide

0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

DRUG

Placebo

matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Sponsors & Collaborators

  • Scios, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • France
  • Germany
  • Greece
  • India
  • Israel
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Sweden
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT00475852 on ClinicalTrials.gov