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
Novartis Pharmaceuticals
Summary
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
Description
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. * Participants who have completed the parent study EOS visit while still on assigned investigational product. Exclusion Criteria: * Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study. * Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician…
Interventions
- DrugPelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Locations (492)
- SEC Clinical Research LLCAndalusia, Alabama
- Heart Center Research LlcHuntsville, Alabama
- Mobile Heart SpecialistsMobile, Alabama
- Mercy Gilbert Medical CenterGilbert, Arizona
- Clinical Research Inst of ArizonaSun City West, Arizona
- Eclipse Clinical ResearchTucson, Arizona