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NCT03523117 · ClinicalTrials.gov registry record · Phase 3
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
A Phase 3 study of Iron Deficiency Anemia, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 79
- Enrollment target
- 16
- Study locations
NCT03523117 is a Phase 3 study of Iron Deficiency Anemia that has completed, run by American Regent. The registered enrollment target is 79 participants, below the 190-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (58% lower). The trial reports 16 study locations across 9 states.
The verdict
NCT03523117, a Phase 3 study of Iron Deficiency Anemia, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 79 participants
- Enrollment target
- 16
- Study locations
Study Summary
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
Conditions Studied
Interventions
- DRUG Ferrous Sulfate
- DRUG Ferric carboxymaltose
Study Locations (16)
Florida
- International Research Partners, Inc. - Doral
- ProHealth Research Center - Doral
- Garden Medical Research, Inc. - Miami
- Miami Clinical Research - Miami
- South Florida Research Phase I-IV - Miami Springs
Texas
- Cook Children's Medical Center - Fort Worth
- Baylor College of Medicine/Texas Children Hospital - Houston
- Tekton Research - San Antonio
Ohio
- Cincinnati Children's Hospital and Medical Center - Cincinnati
- Cincinnati Children's Hospital Medical Center - Cincinnati
Arkansas
- Arkansas Children's Hospital - Little Rock
Indiana
- Riley Hospital for Children,Room 4340 - Indianapolis
Michigan
- Caro Health Plaza - Caro
Missouri
- Galen Research - Chesterfield
New York
- Tiga Pediatrics, PC - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2021-01-29 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03523117
The ClinicalTrials.gov registry entry for NCT03523117 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (58% lower). The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 2 interventions - of which Ferrous Sulfate is the first listed.
NCT03523117 reports 16 study locations spanning 9 distinct geographic areas - top geographies include Florida, Texas, Ohio.
Frequently Asked Questions
What is clinical trial NCT03523117 about?
NCT03523117 is a clinical study titled "Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA". The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
What is the current status of trial NCT03523117?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2019-01-31. Estimated completion is 2021-01-29.
What conditions does trial NCT03523117 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia.
What interventions are being tested in trial NCT03523117?
The interventions under investigation include: Ferrous Sulfate (DRUG), Ferric carboxymaltose (DRUG).
Who is sponsoring clinical trial NCT03523117?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03523117 being conducted?
This trial has 16 study locations across Arkansas, Florida, Indiana, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Iron Deficiency Anemia
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-
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-
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Read our methodology - how this data is sourced, computed, and verified.
Related
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