NCT00354484

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIT45 compared to the current standard of care in postpartum patients.

Detailed description

This is an open label Phase III randomized active control study of postpartum patients with anemia. Patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.

Conditions

• Postpartum Anemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-12-01
• Completion: 2007-01-01
• First posted: 2006-07-20
• Last updated: 2018-02-20
• Results posted: 2013-12-05

Locations

1 site across 1 country: United States