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View trial details
Overview
Official protocol title:
A PHASE III, RANDOMISED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFECT OF BALCINRENONE/DAPAGLIFLOZIN, COMPARED WITH DAPAGLIFLOZIN, ON THE RISK OF HEART FAILURE EVENTS AND CARDIOVASCULAR DEATH IN PATIENTS WITH HEART FAILURE AND IMPAIRED KIDNEY FUNCTION
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.
BALCINRENONE-DAPAGLIFLOZIN / DAPAGLIFLOZIN
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'.
D6402C00012
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
283363
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.
February 28, 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 -
NCT06307652
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
British Columbia
Research Site
New Westminster, British Columbia, V3L 3W4
WITHDRAWN
Research Site
North Vancouver, British Columbia, V7M 2H4
WITHDRAWN
Research Site
Vancouver, British Columbia, V6Z 1Y6
WITHDRAWN
Manitoba
Research Site
Winnipeg, Manitoba, R2H 2A6
RECRUITING
Nova Scotia
Research Site
Sydney, Nova Scotia, B1P 1P3
RECRUITING
Ontario
Research Site
Cambridge, Ontario, N1R 6V6
COMPLETED
Research Site
Cambridge, Ontario, N1R 7R1
RECRUITING
Research Site
Hamilton, Ontario, L8L 5G4
RECRUITING
Research Site
London, Ontario, N6A 5A5
RECRUITING
Research Site
Newmarket, Ontario, L3Y 2P6
RECRUITING
Research Site
North York, Ontario, M6B 3H7
RECRUITING
Research Site
Oakville, Ontario, L6K 3W7
WITHDRAWN
Research Site
Oshawa, Ontario, L1J 2K1
TERMINATED
Research Site
Ottawa, Ontario, K1Y 4W7
WITHDRAWN
Research Site
Peterborough, Ontario, K9J 0B2
WITHDRAWN
Research Site
Thunder Bay, Ontario, P7B 7C7
RECRUITING
Research Site
Toronto, Ontario, M6G 1M2
RECRUITING
Research Site
Waterloo, Ontario, N2T 0C1
RECRUITING
Quebec
Research Site
Chicoutimi, Quebec, G7H 7K9
WITHDRAWN
Research Site
Greenfield Park, Quebec, J4V 2H1
RECRUITING
Research Site
Montreal, Quebec, H1T 1C8
RECRUITING
Research Site
Montreal, Quebec, H2X 0C1
RECRUITING
Research Site
Montreal, Quebec, H3G 1A4
WITHDRAWN
Research Site
Montreal, Quebec, H4J 1C5
RECRUITING
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4
RECRUITING
Research Site
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
WITHDRAWN
Research Site
Trois-Rivières, Quebec, G9A 4P3
RECRUITING