NCT00982007View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

997

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

August 31, 2011

Conditions
Iron Deficiency Anemia
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.

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Inc., Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY