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View trial details
Overview
Official protocol title:
RANDOMIZED TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF FINERENONE ON MORBIDITY AND MORTALITY AMONG HEART FAILURE
PATIENTS WITH LEFT VENTRICULAR EJECTION FRACTION GREATER THAN OR EQUAL TO 40% HOSPITALIZED DUE TO AN EPISODE OF ACUTE
DECOMPENSATED HEART FAILURE (REDEFINE-HF)
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.
FINERENONE
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'.
202301CPC
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
280141
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.
November 16, 2023
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 -
NCT06008197
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
Calgary, AB Investigative Site 11009
Calgary, Alberta, T2N 4Z6
RECRUITING
Edmonton, AB Investigative Site 11018
Edmonton, Alberta, T5H 3V9
RECRUITING
Edmonton, Alberta Investigative Site 11011
Edmonton, Alberta, T6G 2B7
RECRUITING
British Columbia
Kamloops, BC Investigative Site 11021
Kamloops, British Columbia, V2C 2T1
RECRUITING
North Vancouver, BC Investigative Site11020
North Vancouver, British Columbia, V7M2H4
NOT_YET_RECRUITING
Surrey, British Columbia Investigative Site 11012
Surrey, British Columbia, V3V 0C6
RECRUITING
Vancouver, BC Investigative Site 11017
Vancouver, British Columbia, V6E 1M7
RECRUITING
Manitoba
Winnipeg, MB Investigative Site 11006
Winnipeg, Manitoba, R2H 2A6
RECRUITING
Ontario
Cambridge, ON Investigative Site 11003
Cambridge, Ontario, N1R6V6
RECRUITING
London, ON Investigative Site 11010
London, Ontario, N6A 5A5
RECRUITING
North York, Ontario Investigative Site 11007
North York, Ontario, M6B3H7
RECRUITING
Sudbury, ON Investigative Site 11016
Greater Sudbury, Ontario, P3E 5J1
RECRUITING
Toronto, ON Investigative Site 11001
Toronto, Ontario, M5G 2C4
RECRUITING
Toronto, ON Investigative Site 11019
Toronto, Ontario, M5B 1W8
RECRUITING
Toronto, Ontario Investigative Site 11008
Toronto, Ontario, M4N3M5
RECRUITING
Quebec
Sherbrooke, QC Investigative Site 11005
Sherbrooke, Quebec, J1H 5N4
RECRUITING
Saskatchewan
Regina, SK Investigative Site 11022
Regina, Saskatchewan, S4P 0W5
RECRUITING