Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
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ClinicalTrials.gov Identifier: NCT00354484 |
Recruitment Status :
Completed
First Posted : July 20, 2006
Results First Posted : December 5, 2013
Last Update Posted : February 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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Postpartum Anemia | Drug: Ferric Carboxymaltose (FCM) Drug: Ferrous Sulfate tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 291 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | January 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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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. |
Active Comparator: Ferrous Sulfate tablets
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
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Drug: Ferrous Sulfate tablets
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. |
- Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL [ Time Frame: anytime between baseline and end of study or time to intervention ]
- Reported Adverse Events [ Time Frame: anytime between baseline and end of study or time to intervention ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female Subjects able to give consent
- Post partum patients
- Baseline Hgb < /= 10 g/dL
- Agree to practice birth control
Exclusion Criteria:
- Participation in previous clinical trial of this investigational agent
- Known hypersensitivity reaction to active control
- Significant vaginal bleeding
- History of anemia other than iron deficiency anemia
- Anticipated need for surgery during the study
- Active severe infection or malignancy
- Known positive Hepatitis B antigen of Hepatitis C viral antibody
- Known HIV antibodies
- Received an investigational drug within 30 days of screening
- Alcohol abuse within past 6 months
- Hemochromatosis or other iron storage disorders
- Significant cardiovascular disease
- Any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354484
United States, Pennsylvania | |
Luitpold Pharmaceuticals | |
Norristown, Pennsylvania, United States, 19403 |
Responsible Party: | American Regent, Inc. |
ClinicalTrials.gov Identifier: | NCT00354484 |
Other Study ID Numbers: |
1VIT06011 |
First Posted: | July 20, 2006 Key Record Dates |
Results First Posted: | December 5, 2013 |
Last Update Posted: | February 20, 2018 |
Last Verified: | January 2018 |
anemia postpartum |
Anemia Hematologic Diseases |