drugset / Trial / NCT01563367

A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof

NCT01563367

Phase 3 Completed 74 enrolled Pharmacosmos A/S CRO Max Neeman · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery

Timeline

Start
2012-01
Primary completion
2013-08
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iron isomaltoside 1000 Unknown 1000 mg Intravenous

Indications

No indication recorded.