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View trial details
Overview
Official protocol title:
EASI-HF - A PHASE III DOUBLE-BLIND, RANDOMISED, PARALLEL-GROUP SUPERIORITY TRIAL TO EVALUATE EFFICACY AND SAFETY OF THE COMBINED USE OF ORAL BI 690517 AND EMPAGLIFLOZIN COMPARED WITH PLACEBO AND EMPAGLIFLOZIN IN PARTICIPANTS WITH SYMPTOMATIC HEART FAILURE (HF: NYHA II-IV) AND LEFT VENTRICULAR EJECTION FRACTION (LVEF) >40%
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
VICADROSTAT (BI 690517) / EMPAGLIFLOZIN
Medical condition:
The disease or condition that's being studied in the clinical trial.
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
1378-0020
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
288109
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Recruiting
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
July 24, 2024
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 3
For more information:
ClinicalTrials.gov -
NCT06424288
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Accepts healthy volunteers:
No
Locations
Ontario
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
RECRUITING
CardioQuest Research Centre
Sarnia, Ontario, N7T 4P5
RECRUITING
CardioVasc HR Inc.
Saint-Jean-sur-Richelieu, Ontario, J3A 1J2
RECRUITING
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Ontario, H2X 0C1
RECRUITING
Clinical Research Solutions Inc. (Kitchener)
Kitchener, Ontario, N2H5Z8
NOT_YET_RECRUITING
Curnew Medicine Professional Corporation
Hamilton, Ontario, L8L 0A9
RECRUITING
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2
RECRUITING
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1
RECRUITING
James Cha, MD
Oshawa, Ontario, L1J 2K1
RECRUITING
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
RECRUITING
KMH Cardiology Centers (Hamilton)
Stoney Creek, Ontario, L8J 3W2
RECRUITING
KMH Cardiology Centres (Mississauga)
Mississauga, Ontario, L5K 2L3
RECRUITING
Montreal General Hospital - McGill University Health Centre
Montreal, Ontario, H3G 1A4
RECRUITING
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, L6M 0L8
RECRUITING
Royal Alexandra Hospital (Edmonton)
Edmonton, Ontario, T5H 3V9
RECRUITING
Quebec
Diex Recherche (Trois-Rivieres)
Trois-Rivières, Quebec, G9A 4P3
RECRUITING
Jewish General Hospital
Montreal, Quebec, H3T 1E2
RECRUITING
ViaCar Recherches Cliniques Inc. (Greenfield Park)
Greenfield Park, Quebec, J4V 2G8
RECRUITING