Status:
COMPLETED
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Lead Sponsor:
American Regent, Inc.
Conditions:
Postpartum Anemia
Eligibility:
FEMALE
Phase:
PHASE3
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 u...
Eligibility Criteria
Inclusion
- Female Subjects able to give consent
- Post partum patients
- Baseline Hgb \< /= 10 g/dL
- Agree to practice birth control
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00354484
Start Date
May 1 2006
End Date
January 1 2007
Last Update
February 20 2018
Active Locations (1)
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1
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403