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Phase 3Recruiting

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Sponsored by Novartis Pharmaceuticals

About this study

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).

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).

Where this study is enrolling (99)

Show all 99 locations
Who can participate

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 (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
  • ✕Participants are receiving another investigational drug or device before the open-label treatment period.
  • ✕Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
  • ✕Other protocol-defined inclusion/exclusion criteria may apply.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.