Phase 3Active, not recruitingAge-related condition
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 (Industry)
- Enrolment
- 599 planned
- Conditions
- Atherosclerotic Cardiovascular Disease
- Interventions
- Pelacarsen (TQJ230)
- Ages
- adults, older adults
- Registry
- NCT06875973
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Incidence of Adverse events (AEs) or serious adverse events (SAEs)
History
Primary completion expected
Last registry update
Started
Registered