Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

291

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

December 31, 2006

Study Completion Date

January 31, 2007

Conditions
Postpartum Anemia
Interventions
DRUG

Ferric Carboxymaltose (FCM)

Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.

DRUG

Ferrous Sulfate tablets

325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY