Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354484
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2006-07-13
Brief Title:
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Sponsor:
American Regent Inc
Organization:
American Regent Inc
Study Overview
Official Title:
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 up to 6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None