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Pelacarsen Roll-over Extension Program
Pelacarsen Roll-over Extension Program

NCT06875973

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Atherosclerotic Cardiovascular Disease

Interventions: Pelacarsen (TQJ230)

Countries: United States, Puerto Rico

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (97)
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Canoga Park, California, United States
  • Covina, California, United States
  • Garden Grove, California, United States
  • Irvine, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Northridge, California, United States
  • Stanford, California, United States
  • Boca Raton, Florida, United States
  • Cape Coral, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Hialeah, Florida, United States
  • Hialeah, Florida, United States
  • Hollywood, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Miami Lakes, Florida, United States
  • Miramar, Florida, United States
  • Palm Springs, Florida, United States
  • Pembroke Pines, Florida, United States
  • Tampa, Florida, United States
  • + 67 more on CT.gov