CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 361 enrolled
Drug / intervention
Oral iron tablets +1 moredrug
Likely dose
Oral iron tablets 325 mgfrom 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.

Search/NCT00396292
NCT00396292Phase 3Completed

Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia

American Regent, Inc.·interventional·Posted Nov 6, 2006·Updated Feb 5, 2018

In Brief

A Phase 3 clinical trial evaluating Oral iron tablets and VIT-45 for Anemia. Completed, enrolled 361 participants across 1 site.

Detailed Summary

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2006
Enrollment StartFeb 1, 2005
Primary CompletionNov 1, 2005
Study CompletionFeb 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.7 years ago

Interventions

Oral iron tabletsdrug

325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42

VIT-45drug

A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered