Status:
RECRUITING
Pelacarsen Roll-over Extension Program
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 (CTQJ230A1...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 3 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06875973
Start Date
May 19 2025
End Date
January 3 2028
Last Update
August 3 2025
Active Locations (25)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
National Heart Institute
Beverly Hills, California, United States, 90211
3
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States, 33434
4
Proactive Clinical Research
Fort Lauderdale, Florida, United States, 33308