RECRUITING

Pelacarsen Roll-over Extension Program

Description

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).

Conditions

Atherosclerotic Cardiovascular Disease
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Related Conditions:

Atherosclerotic Cardiovascular Disease

Study Overview

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Study Details

Study overview

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).

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

Pelacarsen Roll-over Extension Program

Condition
Atherosclerotic Cardiovascular Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

Parkway Medical Center, Birmingham, Alabama, United States, 35215

Beverly Hills

National Heart Institute, Beverly Hills, California, United States, 90211

Boca Raton

Excel Medical Clinical Trials LLC, Boca Raton, Florida, United States, 33434

Fort Lauderdale

Proactive Clinical Research, Fort Lauderdale, Florida, United States, 33308

Hialeah

National Research Institute, Hialeah, Florida, United States, 33013

Miami Lakes

Inpatient Research Clinical LLC, Miami Lakes, Florida, United States, 33014

Miami

Finlay Medical Research, Miami, Florida, United States, 33126

Pembroke Pines

DBC Research USA, Pembroke Pines, Florida, United States, 33029

Wellington

Cardiology Partners Clinical Research Institute, Wellington, Florida, United States, 33449

Covington

Cardiovascular Associates Research, Covington, Louisiana, United States, 70433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Study Record Dates

2028-01-03