A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo
NCT02172001 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2016-09-28
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.
Conditions
Interventions
- DRUG
-
Iron isomaltoside 1000
- DRUG
-
Natrium Chloride 0,9%
100 ml or 5 ml
Sponsors & Collaborators
-
Pharmacosmos A/S
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Primary Completion
- 2015-03-31
Countries
- United States
Study Locations
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