drugset / Trial / NCT02172001

A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo

NCT02172001

Phase 3 Withdrawn Pharmacosmos A/S
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.

Timeline

Start
Primary completion
2015-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Iron isomaltoside 1000 Unknown 1000 mg Intravenous
Subject Iron isomaltoside 1000 Unknown 1500 mg Intravenous
Subject Iron isomaltoside 1000 Unknown 2000 mg Intravenous