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

PHASE3CompletedINTERVENTIONAL
Enrollment

735

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

July 31, 2009

Study Completion Date

March 31, 2011

Conditions
Anemia
Interventions
DRUG

Ferric Carboxymaltose

15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.

DRUG

Standard Medical Care (SMC)

Per product label

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY

NCT00704353 - Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia | Biotech Hunter | Biotech Hunter