drugset / Trial / NCT00704353

Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

NCT00704353

Phase 3 Completed 735 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent

Timeline

Start
2008-06
Primary completion
2009-07
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent
Comparator Iron dextran Unknown
Comparator Iron sucrose Unknown
Comparator Sodium Ferric Gluconate Complex Unknown

Indications