At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 594 enrolled
Drug / intervention
VIT-45 +1 moredrug
Likely dose
VIT-45 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating VIT-45 and Placebo for Anemia. Completed, enrolled 594 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
Primary CompletionFeb 2006
Study CompletionMay 2006
First PostedAug 2008
TodayJul 2026
First PostedAug 22, 2008
Enrollment StartJul 1, 2005
Primary CompletionFeb 1, 2006
Study CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.9 years ago
Interventions
VIT-45drug
15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously
Placebodrug
for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously