CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,065 enrolled
Drug / intervention
Ferric Carboxymaltose +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03037931
NCT03037931Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency /and Sub-Study

American Regent, Inc.·interventional·Posted Jan 31, 2017·Updated Jul 3, 2024

In Brief

A Phase 3 clinical trial evaluating Ferric Carboxymaltose and Placebo for Heart Failure and Iron-deficiency. Completed, enrolled 3,065 participants across 345 sites in 13 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Iron-deficiency
CountriesAustralia, Bulgaria, Canada, Czechia, Georgia, Hungary, Latvia, Lithuania, New Zealand, Poland, Russia, Ukraine, United States
CollaboratorsDuke Clinical Research Institute

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 31, 2017
Enrollment StartMar 15, 2017
Primary CompletionFeb 2, 2023
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9.4 years ago

Interventions

Ferric Carboxymaltosedrug

Intravenous Iron

Placebodrug

Normal Saline Solution