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NCT02130063 · ClinicalTrials.gov registry record · Phase 3
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
A Phase 3 study, sponsored by Pharmacosmos A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT02130063 is a Phase 3 study that has completed, run by Pharmacosmos A/S. The registered enrollment target is 511 participants.
The verdict
NCT02130063, a Phase 3 study, has completed, sponsored by Pharmacosmos A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
Interventions
- DRUG iron isomaltoside 1000 (Monofer®)
- DRUG iron sucrose (Venofer®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02130063
The ClinicalTrials.gov registry entry for NCT02130063 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmacosmos A/S, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which iron isomaltoside 1000 (Monofer®) is the first listed.
NCT02130063 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02130063 about?
NCT02130063 is a clinical study titled "IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose". The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
What is the current status of trial NCT02130063?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2014-05. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02130063?
The interventions under investigation include: iron isomaltoside 1000 (Monofer®) (DRUG), iron sucrose (Venofer®) (DRUG).
Who is sponsoring clinical trial NCT02130063?
This trial is sponsored by Pharmacosmos A/S, which has 10 total clinical trials registered on ClinicalTrials.gov.
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