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

PHASE3CompletedINTERVENTIONAL

Enrollment

594

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

February 28, 2006

Study Completion Date

May 31, 2006

Conditions

Anemia

Interventions

DRUG

VIT-45

15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously

DRUG

Placebo

for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously

Trial Locations (1)

Luitpold Pharmaceuticals, Norristown