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View trial details
Overview
Official protocol title:
A PHASE III DOUBLE-BLIND, RANDOMISED, PARALLEL-GROUP SUPERIORITY TRIAL TO EVALUATE EFFICACY AND SAFETY OF THE COMBINED USE OF ORAL VICADROSTAT (BI 690517) AND EMPAGLIFLOZIN COMPARED WITH PLACEBO AND EMPAGLIFLOZIN IN PARTICIPANTS WITH TYPE 2 DIABETES, HYPERTENSION AND ESTABLISHED CARDIOVASCULAR DISEASE. (EASI¿-PROTKT)
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 (BI 10773)
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'.
1378-0041
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
298020
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.
June 13, 2025
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 -
NCT07064473
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
Alberta
CaRe Clinic (Calgary)
Calgary, Alberta, T2N 4L7
Recruiting
CARe Clinic (Red Deer)
Red Deer, Alberta, T4P 1K4
Recruiting
Diex Recherche (Quebec)
Quebec, Alberta, G1V 4T3
Recruiting
British Columbia
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4
Recruiting
Medical Arts Research (Kelowna)
Kelowna, British Columbia, V1Y 4N7
Recruiting
Medical Arts Research (North Vancouver)
Vancouver, British Columbia, V7P 2T4
Recruiting
Medical Arts Research (Penticton)
Penticton, British Columbia, V2A 5L5
Recruiting
SMH Cardiology Clinical Trials Inc.
Surrey, British Columbia, V3V 0C6
Recruiting
New Brunswick
GA Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7
Recruiting
Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Recruiting
Ontario
CardioQuest Research Centre
Sarnia, Ontario, N7T 4P5
Recruiting
Centre for Studies in Family Medicine, Western University (LHRI)
London, Ontario, N6G 2M1
Recruiting
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2
Recruiting
Heart Health Institute (Scarborough)
Scarborough Village, Ontario, M1B 4Z8
Recruiting
James Cha, MD
Oshawa, Ontario, L1J 2K1
Recruiting
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
Recruiting
KMH Cardiology Centres (Hamilton)
Stoney Creek, Ontario, L8J 3W2
Recruiting
KMH Cardiology Centres (Mississauga)
Mississauga, Ontario, L5K 2L3
Recruiting
Medical Trust Clinics
Courtice, Ontario, L1E 2J5
Recruiting
PACE (Partners in Advanced Cardiac Evaluation)
Newmarket, Ontario, L3Y 2P6
Recruiting
Saul Vizel Medicine Professional Corporation
Cambridge, Ontario, N1R 7R1
Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Recruiting
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2
Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Recruiting
Quebec
Centre de Medecine Metabolique de Lanaudiere
Terrebonne, Quebec, J6X 4P7
Recruiting
Diex Recherche (Joliette)
Joliette, Quebec, J6E 6A9
Recruiting
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec, J1E 0N8
Recruiting
Diex Recherche (Trois-Rivieres)
Trois Rivieres, Quebec, G9A 4P3
Recruiting
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
Recruiting
Endocrinologie Oasis Inc
Montreal, Quebec, H4J 1E3
Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
Recruiting
THEO Medical - Concorde (Laval)
Laval, Quebec, H7G 2E6
Recruiting
ViaCar Recherches Cliniques Inc. (St-Lambert)
Saint-Lambert, Quebec, J4P 1S9
Recruiting