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NCT00982007 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
A Phase 3 study, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 997
- Enrollment target
NCT00982007 is a Phase 3 study that has completed, run by American Regent. The registered enrollment target is 997 participants.
The verdict
NCT00982007, a Phase 3 study, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 997 participants
- Enrollment target
Study Summary
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.
Interventions
- DRUG IV Iron (standard of care)
- DRUG Ferric Carboxymaltose (FCM)
- DRUG Ferrous Sulfate Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 997 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00982007
The ClinicalTrials.gov registry entry for NCT00982007 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 997 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which IV Iron (standard of care) is the first listed.
NCT00982007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00982007 about?
NCT00982007 is a clinical study titled "Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)". The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.
What is the current status of trial NCT00982007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 997 participants. The study started on 2009-09. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00982007?
The interventions under investigation include: IV Iron (standard of care) (DRUG), Ferric Carboxymaltose (FCM) (DRUG), Ferrous Sulfate Tablets (DRUG).
Who is sponsoring clinical trial NCT00982007?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
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