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Sponsored by: |
Luitpold Pharmaceuticals |
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Information provided by: | Luitpold Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00704028 |
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
Condition | Intervention | Phase |
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Anemia |
Drug: Ferric Carboxymaltose Drug: Iron Dextran |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angelia Butcher | 610-650-4200 | abutcher@lpicrd.com |
Contact: Marc Tokars | 610-650-4200 | mtokars@lpicrd.com |
United States, Pennsylvania | |
Luitpold Pharmaceuticals | Recruiting |
Norristown, Pennsylvania, United States, 19403 |
Study ID Numbers: | 1VIT08020 |
Study First Received: | June 20, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704028 |
Health Authority: | United States: Food and Drug Administration |
Iron-Dextran Complex Metabolic Diseases Ferric Compounds Hematologic Diseases Anemia |
Iron Metabolism Disorders Metabolic disorder Iron Dextrans Anemia, Iron-Deficiency |
Anticoagulants Hematinics Growth Substances Therapeutic Uses Physiological Effects of Drugs Blood Substitutes |
Hematologic Agents Anemia, Hypochromic Trace Elements Micronutrients Plasma Substitutes Pharmacologic Actions |