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Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure

NCT01661634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2157

Last updated 2018-10-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).

Conditions

  • Acute Decompensated Heart Failure

Interventions

DRUG

Ularitide

DRUG

Placebo

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Cardiorentis

    lead INDUSTRY

Principal Investigators

  • Milton Packer, MD

  • Christopher O'Connor, MD

  • William F. Peacock, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-11-30
Completion
2016-03-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

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 NCT01661634 on ClinicalTrials.gov