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Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00740246
First received: August 21, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia


Condition Intervention Phase
Anemia
 Drug: VIT-45
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability

Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Subjects > or = 18 years of age and able to give informed consent
  • Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
  • Screening Visit laboratory Hgb indicative of anemia
  • Screening Visit ferritin indicative of iron deficiency anemia

Exclusion Criteria:

  • Known hypersensitivity to VIT-45
  • Previously received VIT-45
  • Parenteral iron in the 4 weeks prior to screening
  • Chronic or serious active infection
  • Malignancy history
  • AST or ALT greater than the upper limit of normal
  • Anticipated need for surgery or initiation of dialysis during the study
  • Pregnant or sexually active females who are not willing to use an effective form of birth control
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740246

Locations
United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

Publications:
Seid MH, Valaoras TG, Barish CF, Dinh Q. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.
Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.

ClinicalTrials.gov Identifier: NCT00740246     History of Changes
Other Study ID Numbers: 1VIT05006
Study First Received: August 21, 2008
Last Updated: August 21, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
 Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013