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View trial details
Overview
Official protocol title:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL, ASSESSING THE IMPACT OF INCLISIRAN ON MAJOR ADVERSE CARDIOVASCULAR EVENTS IN PARTICIPANTS WITH ESTABLISHED CARDIOVASCULAR DISEASE (VICTORION-2 PREVENT)
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.
INCLISIRAN (KJX839)
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'.
CKJX839B12302
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
256429
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.
Active, not 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.
October 18, 2021
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 -
NCT05030428
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
Novartis Investigative Site
Calgary, Alberta, T2N 4N1
Novartis Investigative Site
Edmonton, Alberta, T5H 4B9
Novartis Investigative Site
Edmonton, Alberta, T6K 4C1
British Columbia
Novartis Investigative Site
Longueuil, British Columbia, J4H 4B9
Novartis Investigative Site
North Vancouver, British Columbia, V7M 2H4
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1M9
Novartis Investigative Site
Vancouver, British Columbia, V6Z 1Y6
Novartis Investigative Site
Victoria, British Columbia, V8R4R2
Novartis Investigative Site
Victoria, British Columbia, V8T 5G4
Novartis Investigative Site
Victoria, British Columbia, V8V 4A1
Manitoba
Novartis Investigative Site
Winnipeg, Manitoba, R3C 0N2
Novartis Investigative Site
Winnipeg, Manitoba, R3L 1Z5
New Brunswick
Novartis Investigative Site
Moncton, New Brunswick, E1G 1A7
Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9
Novartis Investigative Site
Sydney, Nova Scotia, B1P 1P3
Ontario
Novartis Investigative Site
Cambridge, Ontario, N1R 7R1
Novartis Investigative Site
Novartis Investigative Site
Newmarket, Ontario, L3Y 2P6
Novartis Investigative Site
Oakville, Ontario, L6K 3W7
Novartis Investigative Site
Peterborough, Ontario, K9J 0B2
Novartis Investigative Site
Novartis Investigative Site
Scarborough Village, Ontario, M1B 4Z8
Novartis Investigative Site
Scarborough Village, Ontario, M1B 5N1
Novartis Investigative Site
Stoufville, Ontario, L4A 1H2
Quebec
Novartis Investigative Site
Montreal, Quebec, H2X 1R9
Novartis Investigative Site
Montreal, Quebec, H3M 1L3
Novartis Investigative Site
Montreal, Quebec, H4N 2W2
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Saint-Jérôme, Quebec, J7Z 5T3
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G2
Novartis Investigative Site
Terrebonne, Quebec, J6V 2H2
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9