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View trial details
Overview
Official protocol title:
A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER STUDY ASSESSING THE IMPACT OF OLPASIRAN ON MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE AND ELEVATED LIPOPROTEIN (A)
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.
OLPASIRAN (AMG 890)
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'.
20180244
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
269714
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.
December 14, 2022
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 -
NCT05581303
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
ARC Biosystems Incorporated
Vancouver, British Columbia, V6Z 2C7
Discovery Clinical Services Ltd
Victoria, British Columbia, V8T 5G4
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 1B2
Ontario
Brampton Clinical Trials
Brampton, Ontario, L6Z 4N5
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6
CPS Research
Waterloo, Ontario, N2T 0C1
Hamilton Health Sciences Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
LMC Clinical Research Incorporated
Brampton, Ontario, L6S 0C6
LMC Clinical Research Incorporated Thornhill
Concord, Ontario, L4K 4M2
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7
Oakville Cardiovascular Research
Oakville, Ontario, L6K 3W7
One Heart Care
Mississauga, Ontario, L4Y 1M3
Womens College Hospital
Toronto, Ontario, M5S 1B2
Quebec
Centre de sante et de services sociaux du Nord de Lanaudiere
Saint-Charles-Borromee, Quebec, J6E 6J2
Centre Hospitalier Universitaire de Quebec, Centre Hotel-Dieu de Quebec
Clinique des Maladies Lipidiques de Quebec Incorporated
Ecogene-21 Research
Chicoutimi, Quebec, G7H 7K9
Institut de recherches cliniques de Montreal
Montreal, Quebec, H4A 3J1
Institut Universitaire de cardiologie et de pneumologie de Quebec
Research Institute of McGill University Health Center - Glen Site
Montreal, Quebec, H4A 3J1
