Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
American Regent, Inc.
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.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Female Subjects able to give consent
Post partum patients
Baseline Hgb \< /= 10 g/dL
Agree to practice birth control
You may not be if
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
