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NCT00548860 · ClinicalTrials.gov registry record · Phase 3

Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

A Phase 3 study of Anemia, sponsored by American Regent.

Completed
Registry status
Phase 3
Development phase
2,018
Enrollment target
1
Study location

NCT00548860 is a Phase 3 study of Anemia that has completed, run by American Regent. The registered enrollment target is 2,018 participants, above the 400-participant average among 72 other Anemia trials with a reported enrollment target (405% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00548860, a Phase 3 study of Anemia, has completed, sponsored by American Regent.

COMPLETED
Registry status
Phase 3
Development phase
2,018 participants
Enrollment target
1
Study location

Study Summary

The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Conditions Studied

Interventions

  • DRUG Ferric Carboxymaltose
  • DRUG Standard Medical Care (SMC)

Study Locations (1)

Pennsylvania

  • Luitpold Pharmaceuticals - Norristown

Trial Details

FieldValue
Enrollment Target 2,018 participants
Start Date 2007-10
Est. Completion 2009-07
Phase Phase 3

Sponsor

American Regent

34 total trials

What the Registry Record Tells You About NCT00548860

The ClinicalTrials.gov registry entry for NCT00548860 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,018 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 400-participant average among 72 other Anemia trials with a reported enrollment target (405% higher). The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which Ferric Carboxymaltose is the first listed.

NCT00548860 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00548860 about?

NCT00548860 is a clinical study titled "Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients". The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

What is the current status of trial NCT00548860?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,018 participants. The study started on 2007-10. Estimated completion is 2009-07.

What conditions does trial NCT00548860 study?

This clinical trial studies the following conditions: Anemia.

What interventions are being tested in trial NCT00548860?

The interventions under investigation include: Ferric Carboxymaltose (DRUG), Standard Medical Care (SMC) (DRUG).

Who is sponsoring clinical trial NCT00548860?

This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00548860 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.