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NCT06875973 | NOT YET RECRUITING | Atherosclerotic Cardiovascular Disease

Pelacarsen Roll-over Extension Program
Sponsor:

Novartis Pharmaceuticals

Brief Summary:

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).

Condition or disease

Atherosclerotic Cardiovascular Disease

Intervention/treatment

Pelacarsen (TQJ230)

Phase

PHASE3

Detailed Description:

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : NONE
Masking Description : Open label study
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-05-20
Estimated Primary Completion Date : 2027-12-31
Estimated Study Completion Date : 2028-01-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Pelacarsen Roll-over Extension Program

Location Details

NCT06875973

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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