- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00740246
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
August 21, 2008 updated by: American Regent, Inc.
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
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Norristown, Pennsylvania, United States, 19403
- Luitpold Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety and Tolerability
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Registration Dates
First Submitted
August 21, 2008
First Submitted That Met QC Criteria
August 21, 2008
First Posted (Estimate)
August 22, 2008
Study Record Updates
Last Update Posted (Estimate)
August 22, 2008
Last Update Submitted That Met QC Criteria
August 21, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1VIT05006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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