Pelacarsen Roll-over Extension Program

Recruiting now · Phase 3

Conditions studied: Atherosclerotic Cardiovascular Disease

In brief

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).

Key facts

Study ID

NCT06875973

Run by

Novartis Pharmaceuticals

People needed

599

Starts

2025-05-19

Expected to finish

2030-12-08

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• CTMD Research — Palm Springs, Florida, United States (enrolling)
• James A Haley Veterans Hospital — Tampa, Florida, United States (enrolling)
• Hope Clinical Research — Canoga Park, California, United States (enrolling)
• Inpatient Research Clinical LLC — Miami Lakes, Florida, United States (enrolling)
• DBC Research USA — Pembroke Pines, Florida, United States (enrolling)
• New Tampa Health — Tampa, Florida, United States (enrolling)
• Long Beach Clinical Trials — Long Beach, California, United States (enrolling)
• Angel City Research Inc — Los Angeles, California, United States (enrolling)
• Parkway Medical Center — Birmingham, Alabama, United States (enrolling)
• Stanford Health Care — Stanford, California, United States (enrolling)
• National Heart Institute — Beverly Hills, California, United States (enrolling)
• C and A Clinical Trials — Cape Coral, Florida, United States (enrolling)
• Proactive Clinical Research — Fort Lauderdale, Florida, United States (enrolling)
• University of Calif Irvine Med Cntr — Irvine, California, United States (enrolling)
• National Research Institute — Hialeah, Florida, United States (enrolling)
• Sister Life Research Inc — Hialeah, Florida, United States (enrolling)
• Zenith Clinical Research — Hollywood, Florida, United States (enrolling)
• Columbus Clinical Services LLC — Miami, Florida, United States (enrolling)
• Cardiology and Medicine Clinic PA — Little Rock, Arkansas, United States (enrolling)
• Infinite Clinical Research — Miami, Florida, United States (enrolling)
• International Research Associates LLC — Miami, Florida, United States (enrolling)
• Baptist Health South — Miami, Florida, United States (enrolling)
• A&A Research Group Inc — Miami, Florida, United States (enrolling)
• Inpatient Research Clinical LLC — Miami Lakes, Florida, United States (enrolling)
• Cardiology Partners Clinical Research Institute — Wellington, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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