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NCT00548860 · ClinicalTrials.gov registry record · Phase 3
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
A Phase 3 study of Anemia, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,018
- Enrollment target
- 1
- Study location
NCT00548860: Completed Phase 3 study of Anemia, sponsored by American Regent.
NCT00548860 is a Phase 3 study of Anemia that has completed, run by American Regent. The registered enrollment target is 2,018 participants, above the 400-participant average among 72 other Anemia trials with a reported enrollment target (405% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00548860, a Phase 3 study of Anemia, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,018 participants
- Enrollment target
- 1
- Study location
Study Summary
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
Primary Outcome
Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).
Conditions Studied
Interventions
- DRUG Ferric Carboxymaltose
- DRUG Standard Medical Care (SMC)
Study Locations (1)
Pennsylvania
- Luitpold Pharmaceuticals - Norristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,018 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00548860 record still lists
NCT00548860 is an interventional study that assigns participants to a tested intervention. Its 2,018 participants enrollment target places it among the larger protocols in the corpus, above the 400-participant average among 72 other Anemia trials with a reported enrollment target (405% higher).
The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which Ferric Carboxymaltose is the first listed.
NCT00548860 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00548860 about?
NCT00548860 is a clinical study titled "Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients". The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
What is the current status of trial NCT00548860?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,018 participants. The study started on 2007-10. Estimated completion is 2009-07.
What conditions does trial NCT00548860 study?
This clinical trial studies the following conditions: Anemia.
What interventions are being tested in trial NCT00548860?
The interventions under investigation include: Ferric Carboxymaltose (DRUG), Standard Medical Care (SMC) (DRUG).
Who is sponsoring clinical trial NCT00548860?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00548860 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00548860's enrollment target sits among peer trials
2,018 3rd of 72 higher than 70 of 72 other Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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