An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pelacarsen (TQJ230): pelacarsen 80mg s.c. monthly
Study summary
This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.
Eligibility
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 (646)
| Facility | City | Region | Status |
|---|---|---|---|
| SEC Clinical Research LLC | Andalusia | Alabama | |
| Heart Center Research Llc | Huntsville | Alabama | |
| Mobile Heart Specialists | Mobile | Alabama | |
| Mercy Gilbert Medical Center | Gilbert | Arizona | |
| Clinical Research Inst of Arizona | Sun City West | Arizona | |
| Eclipse Clinical Research | Tucson | Arizona | |
| Cardiology and Medicine Clinic PA | Little Rock | Arkansas | |
| Cardiovascular Res Found | Beverly Hills | California | |
| National Heart Institute | Beverly Hills | California | |
| Valley Clinical Trials Inc | Covina | California | |
| Diabetes Lipid Management Center | Huntington Beach | California | |
| University of Calif Irvine Med Cntr | Irvine | California | |
| Memorial Care Health System | Long Beach | California | |
| Keck Medical Center USC | Los Angeles | California | |
| Valley Clinical Trials | Northridge | California | |
| Stanford University Medical Center | Palo Alto | California | |
| University of California San Diego | San Diego | California | |
| UCSF | San Francisco | California | |
| Manshadi Heart Institute | Stockton | California | |
| Interv Cardiology Med Grp | West Hills | California | |
| Univ Of Color Anschutz Med Center | Aurora | Colorado | |
| Bridgeport Hospital | Bridgeport | Connecticut | |
| Hartford Hospital | Hartford | Connecticut | |
| Chase Medical Research LLC | Waterbury | Connecticut | |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | |
| Bay Area Cardiology Assoc | Brandon | Florida | |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | |
| Advanced Research for Health Improvement LLC | Naples | Florida | |
| Peace River Cardiovascular Center | Port Charlotte | Florida | |
| Progressive Medical Research | Port Orange | Florida | |
| East Coast Inst for Research LLC | Saint Augustine | Florida | |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | |
| Piedmont Heart Institute | Atlanta | Georgia | |
| Emory University | Atlanta | Georgia | |
| Cardiovascular Consultants of S GA | Thomasville | Georgia | |
| Rush University Medical Center | Chicago | Illinois | |
| Advocate Lutheran General Childrens Hospital | Park Ridge | Illinois | |
| Krannert Institute of Cardiology | Indianapolis | Indiana | |
| Uni Of Iowa Hospitals And Clinics | Iowa City | Iowa | |
| University of Kansas Hospital | Kansas City | Kansas |
+ 606 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in the UK
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 the UK