drugset / Trial / NCT00982007

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

NCT00982007

Phase 3 Completed 997 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-09
Primary completion
2011-03
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 1500 mg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 325 mg Oral