Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

Completed · Phase 3

Conditions studied: Postpartum Anemia

In brief

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.

Key facts

Study ID

NCT00354484

Run by

American Regent, Inc.

People needed

291

Starts

2006-05-01

Expected to finish

2007-01-01

Last updated by the study team

2018-02-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female Subjects able to give consent
• Post partum patients
• Baseline Hgb < /= 10 g/dL
• Agree to practice birth control

You may not qualify 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

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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