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Active Not 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). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06875973). StuddyBuddy aggregates publicly available trial information.