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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00740246
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : August 22, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Anemia Drug: VIT-45 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Safety and Tolerability

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: August 22, 2008
Last Verified: August 2008

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