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| Tracking Information | |||||||||
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| First Received Date † | June 20, 2008 | ||||||||
| Last Updated Date | October 15, 2008 | ||||||||
| Start Date † | June 2008 | ||||||||
| Current Primary Outcome Measures † |
Safety and Tolerability | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00704353 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Safety and Tolerability of a Single Dose of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia | ||||||||
| Official Title † | 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 |
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| Brief Summary | The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment | ||||||||
| Condition † | Anemia | ||||||||
| Intervention † | Drug: Ferric Carboxymaltose | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | |||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00704353 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Luitpold Pharmaceuticals | ||||||||
| Collaborators †† | |||||||||
| Investigators † | |||||||||
| Information Provided By | Luitpold Pharmaceuticals | ||||||||
| Verification Date | October 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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