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

Last updated:
2026-07-11
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View trial details

Overview

Official protocol title:

PROTOCOL TITLE: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF FERRIC CARBOXYMALTOSE (US TRADE NAME: INJECTAFER) AS TREATMENT FOR HEART FAILURE WITH IRON DEFICIENCY

Intervention/treatment:
FERRIC CARBOXYMALTOSE
Medical condition:
HEART FAILURE
Protocol code:
1VIT15043
Control number:
206939
Status:
Closed
Approved:
July 17, 2017
Date Completed:
Trial phase:
Phase 3
For more information:
ClinicalTrials.gov - NCT03037931
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
18 Years and older
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
Elizabeth Ernst, Global Executive Director of Regulatory Affairs
Organization
American Regent, Inc.
Phone:
631-605-5753
Extension 3551
Sponsor
AMERICAN REGENT, INC

Locations

Alberta

Royal Alexandria Hospital
Edmonton, Alberta, A1B 3V6
South Edmonton Cardiology Consultants
Edmonton, Alberta, T6L 6K3
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
University of Calbary
Calgary, Alberta, T2N 4Z6

British Columbia

Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4
SMH Cardiology Clinical Trials
Surrey, British Columbia, V3V 0C6
St. Paul's Hospital
Vancouver, British Columbia, V6E 1M7
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2

New Brunswick

G.A. Research Associates, Ltd.
Moncton, New Brunswick, M5B 1W8

Newfoundland and Labrador

Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6

Nova Scotia

Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7

Ontario

Cambridge Cardiac Care Center
Cambridge, Ontario, N1R 6V6
London Health Sciences Center (LHSC)
London, Ontario, N6A 5A5
Manna Research Inc., Burlington South
Burlington, Ontario, L7R 1A4
Sinai Health System - Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Vizel Cardiac Research
Cambridge, Ontario, N1R 7R1

Quebec

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec
Trois-Rivières, Quebec, G8Z 3R9
CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
Saint-Georges, Quebec, G5Y 4T8
Clinique de Cardiologie de Lévis
Lévis, Quebec, G6V 4Z5
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, G1V 4G5
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Recherche Medical St-Jerome Inc.
Saint-Jérôme, Quebec, J7Z 5T3

Saskatchewan

Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8

Results

See the results from the trial NCT03037931. This is an external link. The information is not authorized by the Government of Canada.

Date posted:
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