Trials / Completed
CompletedNCT00704353
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 735 (actual)
- Sponsor
- American Regent, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ferric Carboxymaltose | 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. |
| DRUG | Standard Medical Care (SMC) | Per product label |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2009-07-01
- Completion
- 2011-03-01
- First posted
- 2008-06-24
- Last updated
- 2018-02-20
- Results posted
- 2013-11-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00704353. Inclusion in this directory is not an endorsement.