At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 291 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM) +1 moredrug
Likely dose
Ferric Carboxymaltose (FCM) 2,500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
In Brief
A Phase 3 clinical trial evaluating Ferric Carboxymaltose (FCM) and Ferrous Sulfate tablets for Postpartum Anemia. Completed, enrolled 291 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Anemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedJul 2006
Primary CompletionDec 2006
Study CompletionJan 2007
TodayJul 2026
First PostedJul 20, 2006
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2006
Study CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.9 years ago
Interventions
Ferric Carboxymaltose (FCM)drug
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.
Ferrous Sulfate tabletsdrug
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.