Clinical Trials in South Korea / NCT07517263
Recruiting
Phase 3
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
NCT07517263 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Cardiovascular Disease and Lipoprotein(a)
Investigational drug(s) / intervention(s)
Pelacarsen (TQJ230): pelacarsen 80mg s.c. monthly
Study summary
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
Eligibility
Inclusion Criteria:
* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study EOS visit while still on assigned investigational product.
Exclusion Criteria:
* Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
* Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
* Participants are receiving another investigational drug or device before the open-label treatment period.
* Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- Number of participants with Adverse events — Up to 36 months
Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.
Trial sites (655)
| Facility | City | Region | Status |
|---|---|---|---|
| SEC Clinical Research LLC | Andalusia | Alabama | Recruiting |
| Heart Center Research Llc | Huntsville | Alabama | Recruiting |
| Mobile Heart Specialists | Mobile | Alabama | Recruiting |
| Mercy Gilbert Medical Center | Gilbert | Arizona | Recruiting |
| Clinical Research Inst of Arizona | Sun City West | Arizona | Recruiting |
| Eclipse Clinical Research | Tucson | Arizona | Recruiting |
| Cardiology and Medicine Clinic PA | Little Rock | Arkansas | Recruiting |
| Cardiovascular Res Found | Beverly Hills | California | Recruiting |
| National Heart Institute | Beverly Hills | California | Recruiting |
| Valley Clinical Trials Inc | Covina | California | Active Not Recruiting |
| Diabetes Lipid Management Center | Huntington Beach | California | Recruiting |
| University of Calif Irvine Med Cntr | Irvine | California | Recruiting |
| Memorial Care Health System | Long Beach | California | Recruiting |
| Keck Medical Center USC | Los Angeles | California | Recruiting |
| Valley Clinical Trials | Northridge | California | Active Not Recruiting |
| Stanford University Medical Center | Palo Alto | California | Recruiting |
| University of California San Diego | San Diego | California | Recruiting |
| UCSF | San Francisco | California | Recruiting |
| Helping Hands Medical Associates INC | Santa Ana | California | Withdrawn |
| Manshadi Heart Institute | Stockton | California | Recruiting |
| Interv Cardiology Med Grp | West Hills | California | Active Not Recruiting |
| Univ Of Color Anschutz Med Center | Aurora | Colorado | Recruiting |
| Bridgeport Hospital | Bridgeport | Connecticut | Recruiting |
| Hartford Hospital | Hartford | Connecticut | Recruiting |
| Chase Medical Research LLC | Waterbury | Connecticut | Recruiting |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | Recruiting |
| Bay Area Cardiology Assoc | Brandon | Florida | Recruiting |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | Recruiting |
| Advanced Research for Health Improvement LLC | Naples | Florida | Recruiting |
| Peace River Cardiovascular Center | Port Charlotte | Florida | Recruiting |
| Progressive Medical Research | Port Orange | Florida | Recruiting |
| East Coast Inst for Research LLC | Saint Augustine | Florida | Recruiting |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | Recruiting |
| Piedmont Heart Institute | Atlanta | Georgia | Active Not Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| Cardiovascular Consultants of S GA | Thomasville | Georgia | Recruiting |
| Rush University Medical Center | Chicago | Illinois | Recruiting |
| Advocate Lutheran General Childrens Hospital | Park Ridge | Illinois | Recruiting |
| Krannert Institute of Cardiology | Indianapolis | Indiana | Recruiting |
| Uni Of Iowa Hospitals And Clinics | Iowa City | Iowa | Active Not Recruiting |
+ 615 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in South Korea
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07517263 on ClinicalTrials.gov ↗ ← All trials in South Korea