Pelacarsen Roll-over Extension Program
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of Adverse events (AEs) or serious adverse events (SAEs)
Time frame: Up to 48 months
Secondary Endpoints
Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study
Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study
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.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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