drugset / Trial / NCT00354484
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-05
- Primary completion
- 2006-12
- Completion
- 2007-01
Publications
- Results Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.
- Results Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: A Randomized Controlled Study. Southern Medical Association Scientific Assembly 2008.
- Results Seid MH, Derman RJ, Baker JB, Banach W, Goldberg C, Rogers R. Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol. 2008 Oct;199(4):435.e1-7. doi: 10.1016/j.ajog.2008.07.046.
- Results Seid MH, Rogers R, Dinh Q. The Safety and Tolerability of Ferric Carboxymaltose in Treating Postpartum Women with Iron Dediciency Anemia. American College of Obstetrics & Gynecology District Meeting 2007.
- Results Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Managment 6th Annual Meeting 2007.
- Results Goodnough LT. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: a Randomized Controlled Study. Nordic Conference of Obstetrics & Gynecology 2008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric carboxymaltose | Other / unclassified | 2500 mg | Intravenous |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 325 mg | Oral |
Indications
No indication recorded.