CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 997 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM) +3 moredrug
Likely dose
Ferric Carboxymaltose (FCM) 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00982007
NCT00982007Phase 3Completed
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A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

American Regent, Inc.·interventional·Posted Sep 22, 2009·Updated Feb 20, 2018

In Brief

A Phase 3 clinical trial evaluating Ferric Carboxymaltose (FCM), Ferrous Sulfate Tablets, and 1 other intervention for Iron Deficiency Anemia. Completed, enrolled 997 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.8 years ago

Interventions

Ferric Carboxymaltose (FCM)drug

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

Ferrous Sulfate Tabletsdrug

325 mg Ferrous Sulfate tablets taken orally three times a day

IV Iron (standard of care)drug

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

Ferric Carboxymaltose (FCM)drug

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