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Recruiting
NCT06875973
Pelacarsen Roll-over Extension Program
Conditions: Atherosclerotic Cardiovascular Disease
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 599
Sponsor: Novartis Pharmaceuticals
Location: Parkway Medical Center Birmingham Alabama
Summary
This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).
Eligibility Criteria
Inclusion Criteria:
* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study and received the assigned study treatment at the time of its completion
Exclusion Criteria:
* Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
* Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
* Participants who are receiving another investigational drug or device before the open-label treatment period
* Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator
Other protocol-defined inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT06875973). StuddyBuddy aggregates publicly available trial information.