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Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

NCT00982007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 997

Last updated 2018-02-20

Study results available
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Summary

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

Conditions

Interventions

DRUG

Ferric Carboxymaltose (FCM)

A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

DRUG

Ferrous Sulfate Tablets

325 mg Ferrous Sulfate tablets taken orally three times a day

DRUG

IV Iron (standard of care)

IV standard of care (other IV iron) per the Investigator's discretion

DRUG

Ferric Carboxymaltose (FCM)

A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-03-31
Completion
2011-08-31

Countries

  • United States

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 NCT00982007 on ClinicalTrials.gov