drugset / Trial / NCT01290315

Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

NCT01290315

Phase 2 Completed 49 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects.

Timeline

Start
2009-08
Primary completion
2013-03
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 500 mg Intravenous
Subject Ferric carboxymaltose Other / unclassified 750 mg Intravenous
Comparator Iron dextran Unknown 750 mg Intravenous
Comparator Iron sucrose Unknown 500 mg Intravenous