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A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

NCT01453608 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2015-03-18

No results posted yet for this study

Summary

The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.

Conditions

Interventions

DRUG

Ferinject (ferric carboxymaltose)

Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0

DRUG

Placebo (saline)

Subjects will receive Placebo (saline) intravenously on Day 0

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Piotr Ponikowski, MD · Cardiology Department - Centre for Heart Disease - Clinical Military Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-02-28
Completion
2015-01-31

Countries

  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01453608 on ClinicalTrials.gov