A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial
Trial status: Authorised
Time to the first occurrence of 4P-MACE from parent study baseline, Time to the first occurrence of 4P-MACE from OLE study baseline, Cumulative number of 4P-MACE over time from parent study baseline, Cumulative number of 4P-MACE over time from OLE study baseline, Observed value and change in Lp(a) from the parent study baseline, Observed value and change in Lp(a) from the OLE study baseline
● Occurrence of the followings: • Treatment Emergent Adverse Events (TEAEs) • Treatment Emergent Serious Adverse Events (TESAEs) • Treatment discontinuations due to TEAEs/TESAEs, ● TEAEs of special interest Observed value or change/shift from baseline in: • Safety laboratory measures • Vital signs
Description
Time to the first occurrence of 4P-MACE from parent study baseline, Time to the first occurrence of 4P-MACE from OLE study baseline, Cumulative number of 4P-MACE over time from parent study baseline, Cumulative number of 4P-MACE over time from OLE study baseline, Observed value and change in Lp(a) from the parent study baseline, Observed value and change in Lp(a) from the OLE study baseline
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 2777 participants
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