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Recruiting Phase 3 NCT06875973

Pelacarsen Roll-over Extension Program

Trial Parameters

Condition Atherosclerotic Cardiovascular Disease
Sponsor Novartis Pharmaceuticals
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 599
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2025-05-19
Completion 2030-12-08
Interventions
Pelacarsen (TQJ230)

Brief 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.

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