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View trial details
Overview
Official protocol title:
OBICETRAPIB AND CARDIOVASCULAR OUTCOMES: A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFECT OF 10 MG OBICETRAPIB IN PARTICIPANTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD) WHO ARE NOT ADEQUATELY CONTROLLED DESPITE MAXIMALLY TOLERATED LIPID-MODIFYING THERAPIES
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.
OBICETRAPIB (TA-8995)
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'.
TA-8995-304
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
260653
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.
February 17, 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 -
NCT05202509
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
Medical Arts Health Research Group - Kamloops
Kamloops, British Columbia, V2C 5T1
Medical Arts Health Research Group - North Vancouver
North Vancouver, British Columbia, V7M 2H4
The Medical Arts Health Research Group - Penticton
Penticton, British Columbia, V2A 5L5
Manitoba
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Ontario
Brampton Clinical Trials
Brampton, Ontario, L4K 4M2
Centre de recherche clinique de Laval
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2
KMH Cardiology & Diagnostic Centres - Hamilton
Stoney Creek, Ontario, L8J 3W2
KMH Cardiology & Diagnostic Centres - Mississauga
Mississauga, Ontario, K9J 0B2
LMC Diabetes & Endocrinology Ltd. - Thornhill
Concord, Ontario, L4K 4M2
Quebec
CardioVasc HR
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Estrie -Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4
Diex Recherche Trois-Rivieres, Inc
Trois-Rivières, Quebec, G9A 4P3
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 6P6
Discovery Clinical Services, Ltd
Victoria, Quebec, J3A 1J2
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
