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NCT03037931 · ClinicalTrials.gov registry record · Phase 3

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

A Phase 3 study, sponsored by American Regent.

Completed
Registry status
Phase 3
Development phase
3,065
Enrollment target

NCT03037931: Completed Phase 3 study, sponsored by American Regent.

NCT03037931 is a Phase 3 study that has completed, run by American Regent. The registered enrollment target is 3,065 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (297% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03037931, a Phase 3 study, has completed, sponsored by American Regent.

COMPLETED
Registry status
Phase 3
Development phase
3,065 participants
Enrollment target

Study Summary

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

Primary Outcome

The number of participants who died out of the total treated group.

Interventions

  • DRUG Placebo
  • DRUG Ferric Carboxymaltose

Trial Details

FieldValue
Enrollment Target 3,065 participants
Start Date 2017-03-15
Est. Completion 2023-02-02
Phase Phase 3
American Regent

34 total trials

What the finished NCT03037931 record still lists

NCT03037931 is an interventional study that assigns participants to a tested intervention. Its 3,065 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (297% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03037931 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03037931 about?

NCT03037931 is a clinical study titled "Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study". The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

What is the current status of trial NCT03037931?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,065 participants. The study started on 2017-03-15. Estimated completion is 2023-02-02.

What interventions are being tested in trial NCT03037931?

The interventions under investigation include: Placebo (DRUG), Ferric Carboxymaltose (DRUG).

Who is sponsoring clinical trial NCT03037931?

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

How this trial's enrollment target compares

Where NCT03037931's enrollment target sits among peer trials

3,065 77th of 2000 higher than 1,924 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03037931, the US trial registry maintained by the National Library of Medicine. NCT03037931 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.