Conditions: Postpartum Anemia
Keywords: anemia postpartum
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 291
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 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. arm 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets
Intervention descriptions: intervention 1: 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. intervention 2: 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.

Protocol document: