Pelacarsen Roll-over Extension Program
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT06875973
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Atherosclerotic Cardiovascular Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pelacarsen (TQJ230) — DRUGpelacarsen 80mg s.c. monthly
Study Details
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).
Key Dates
- Start date
- May 19, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 8, 2030
- Completion
- Dec 8, 2030
Study Design
- Enrollment
- 599 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Pelacarsen (TQJ230)open-label pelacarsen 80mg
Primary Outcome Measure
Incidence of Adverse events (AEs) or serious adverse events (SAEs) [ Time Frame: Up to 48 months ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (91)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | James Sullivan (PRINCIPAL_INVESTIGATOR) |
| Cardiology and Medicine Clinic PA | Little Rock | Arkansas | 72204 | Joe L Hargrove (PRINCIPAL_INVESTIGATOR) |
| National Heart Institute | Beverly Hills | California | 90211 | Norman Lepor (PRINCIPAL_INVESTIGATOR) |
| Hope Clinical Research | Canoga Park | California | 91303 | Anitha Roobalingam Hessam Aazami (PRINCIPAL_INVESTIGATOR) |
| Valley Clinical Trials Inc | Covina | California | 91723 | Breanna Culver Fahed Bitar (PRINCIPAL_INVESTIGATOR) |
| NICRs Research Center | Garden Grove | California | 92844 | Mallu Reddy (PRINCIPAL_INVESTIGATOR) |
| University of Calif Irvine Med Cntr | Irvine | California | 92660 | Ailin Barseghian El-Farra (PRINCIPAL_INVESTIGATOR) |
| Long Beach Clinical Trials | Long Beach | California | 90806 | Suzanne Fussell (PRINCIPAL_INVESTIGATOR) |
| Angel City Research Inc | Los Angeles | California | 90026 | Maira Jackson Felix Sigal (PRINCIPAL_INVESTIGATOR) |
| California Medical Research Associates Inc | Northridge | California | 91324 | Jigar Kadakia (PRINCIPAL_INVESTIGATOR) |
| Stanford Health Care | Stanford | California | 94305 | Tamara Bazouzi Abha Khandelwal (PRINCIPAL_INVESTIGATOR) |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | 33434 | - |
| C and A Clinical Trials | Cape Coral | Florida | 33990 | Sildey Mas Hernandez Juan Antonio Carmona Herrera (PRINCIPAL_INVESTIGATOR) |
| Proactive Clinical Research | Fort Lauderdale | Florida | 33308 | David Mishkin (PRINCIPAL_INVESTIGATOR) |
| Proactive Clinical Research | Fort Lauderdale | Florida | 33308 | - |
| National Research Institute | Hialeah | Florida | 33013 | Leonor Balbuena Raul Alonso (PRINCIPAL_INVESTIGATOR) |
| Sister Life Research Inc | Hialeah | Florida | 33013 | Idania Melo Fernandez (PRINCIPAL_INVESTIGATOR) |
| Zenith Clinical Research | Hollywood | Florida | 33021 | Moises Issa (PRINCIPAL_INVESTIGATOR) |
| A&A Research Group Inc | Miami | Florida | 33186 | Rafael Crespo (PRINCIPAL_INVESTIGATOR) |
| Baptist Health South | Miami | Florida | 33173 | Adedapo Iluyomade (PRINCIPAL_INVESTIGATOR) |
| Columbus Clinical Services LLC | Miami | Florida | 33125 | Sara Llerena (PRINCIPAL_INVESTIGATOR) |
| Finlay Medical Research | Miami | Florida | 33126 | - |
| Infinite Clinical Research | Miami | Florida | 33133 | Sander Fernandez (PRINCIPAL_INVESTIGATOR) |
| International Research Associates LLC | Miami | Florida | 33156 | Cristian Breton (PRINCIPAL_INVESTIGATOR) |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | Alexis Gutierrez (PRINCIPAL_INVESTIGATOR) |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | Dora Gutierrez Jose Contreras (PRINCIPAL_INVESTIGATOR) |
| FXM Clin Res Miramar LLC | Miramar | Florida | 33027 | - |
| CTMD Research | Palm Springs | Florida | 33406 | Luis Castillo (PRINCIPAL_INVESTIGATOR) |
| DBC Research USA | Pembroke Pines | Florida | 33029 | Alvaro Murcia (PRINCIPAL_INVESTIGATOR) |
| James A Haley Veterans Hospital | Tampa | Florida | 33612 | David Whitaker (PRINCIPAL_INVESTIGATOR) |
| New Tampa Health | Tampa | Florida | 33603 | Niubis Miranda Esther Echevarria-Crespo (PRINCIPAL_INVESTIGATOR) |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | 33449 | Duccio Baldari (PRINCIPAL_INVESTIGATOR) |
| Flourish Research | Winter Park | Florida | 32789 | - |
| Flourish Research | Winter Park | Florida | 32789 | Kristi Norton Sara Collins (PRINCIPAL_INVESTIGATOR) |
| Morehouse School Of Medicine | Atlanta | Georgia | 30310 | Priscilla Igho-Pemu (PRINCIPAL_INVESTIGATOR) |
| Atlanta Heart Specialists LLC | Tucker | Georgia | 30084 | David Suh (PRINCIPAL_INVESTIGATOR) |
| Chicago Clinical Research Inst | Chicago | Illinois | 60607 | Dennis Levinson (PRINCIPAL_INVESTIGATOR) |
| Synexus Clinical Research US Inc | Chicago | Illinois | 60602 | - |
| Cardiovascular Associates Research | Covington | Louisiana | 70433 | Vicki L Nicely Dale Presser (PRINCIPAL_INVESTIGATOR) |
| Omega Clinical Research | Metairie | Louisiana | 70006 | Tuan-Huy Tran (PRINCIPAL_INVESTIGATOR) |
| CV Ins of the South | Opelousas | Louisiana | 70570 | Siby George Ayalloore (PRINCIPAL_INVESTIGATOR) |
| Monroe Research Llc | West Monroe | Louisiana | 71291 | Assad Mouhaffel (PRINCIPAL_INVESTIGATOR) |
| Southern Clin Research Clinic | Zachary | Louisiana | 70791 | - |
| Ascension Saint Agnes Heart Care | Baltimore | Maryland | 21229 | Martin Albornoz (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins Univ School of Med | Baltimore | Maryland | 21287 | Thorsten Leucker (PRINCIPAL_INVESTIGATOR) |
| Sinai Ct for Throm Res and Drug Dev | Baltimore | Maryland | 21209 | Paul Gurbel (PRINCIPAL_INVESTIGATOR) |
| Metropolitan Cardiovascular Consultants Llc | Beltsville | Maryland | 20705 | Ayim Akyea-Djamson (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins University | Columbia | Maryland | 21044 | Daniel Kim (PRINCIPAL_INVESTIGATOR) |
| Anderson Medical Research | Ft. Washington | Maryland | 20744 | - |
| Capitol Cardiology Associates | Lanham | Maryland | 20706 | Vineet Venugopal (PRINCIPAL_INVESTIGATOR) |
| MD Medical Research | Oxon Hill | Maryland | 20745 | John Hakim (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Meghan McCarthy Sachin Parikh (PRINCIPAL_INVESTIGATOR) |
| Aa Mrc Llc | Flint | Michigan | 48504 | - |
| Aa Mrc Mhs | Flint | Michigan | 48503 | Khalid Ahmed (PRINCIPAL_INVESTIGATOR) |
| Elite Clinical Research | Jackson | Mississippi | 39202 | Candy Thomas Honey East (PRINCIPAL_INVESTIGATOR) |
| Stern Cardiovascular Foundation Inc | Southaven | Mississippi | 38671 | Dharmesh Patel (PRINCIPAL_INVESTIGATOR) |
| Las Vegas Endocrinology | Henderson | Nevada | 89074 | Quang Nguyen (PRINCIPAL_INVESTIGATOR) |
| AB Clinical Trials | Las Vegas | Nevada | 89119 | Atoya Adams (PRINCIPAL_INVESTIGATOR) |
| Clinical Research of South Nevada | Las Vegas | Nevada | 89121 | Roger Estevez (PRINCIPAL_INVESTIGATOR) |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | Glaucia Dos Santos-Vaccaro Tudor D Vagaonescu (PRINCIPAL_INVESTIGATOR) |
| Overlook Medical Center | Summit | New Jersey | 07901 | Robert Fishberg (PRINCIPAL_INVESTIGATOR) |
| Jamaica Hospital Medical Center | Richmond Hill | New York | 11418 | David Coven (PRINCIPAL_INVESTIGATOR) |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | Awawu Igbinadolor (PRINCIPAL_INVESTIGATOR) |
| Alliance Medical Ministry | Raleigh | North Carolina | 27610 | Luis Molina Edwin Burkett (PRINCIPAL_INVESTIGATOR) |
| NexGen Research | Lima | Ohio | 45801 | Nonso Ezema (PRINCIPAL_INVESTIGATOR) |
| Care Access Research | Easton | Pennsylvania | 18045 | Devan Guagenti Jimmy Alele (PRINCIPAL_INVESTIGATOR) |
| TCV Clinical Studies | Linwood | Pennsylvania | 19061 | Michael Cosgrove Edward Stankiewicz (PRINCIPAL_INVESTIGATOR) |
| Apex Cardiology Research Associates of Jackson | Jackson | Tennessee | 38301 | Mohsin Alhaddad (PRINCIPAL_INVESTIGATOR) |
| Plano Primary Care Clinic | Allen | Texas | 75002-3688 | Muhammad Moin Farooqi (PRINCIPAL_INVESTIGATOR) |
| Pharma Tex Research | Amarillo | Texas | 79106 | David Brabham (PRINCIPAL_INVESTIGATOR) |
| North Hills Medical Research Inc | Bedford | Texas | 76021 | - |
| SW Family Medicine Associates | Dallas | Texas | 75235 | Chrisette Dharma (PRINCIPAL_INVESTIGATOR) |
| David Turbay MD PLLC | El Paso | Texas | 79905 | David Turbay (PRINCIPAL_INVESTIGATOR) |
| Angiocardiac Care of Texas PA | Houston | Texas | 77025 | Amin Karim (PRINCIPAL_INVESTIGATOR) |
| Dallas Heart and Vascular Consultants PA | Houston | Texas | 77084 | Syed Humayun Naqvi (PRINCIPAL_INVESTIGATOR) |
| Dallas Heart and Vascular Consultants PA | Houston | Texas | 77084 | - |
| Dallas Heart and Vascular Consultants PA | Houston | Texas | 77084 | Sairabano Razzak Imran Afridi (PRINCIPAL_INVESTIGATOR) |
| Epic Clinical Research | Lewisville | Texas | 75057 | Manjoo Sharma (PRINCIPAL_INVESTIGATOR) |
| The Heart Institute of East Texas | Lufkin | Texas | 75904 | Ramah Venessa Kirk Mohammed Khan (PRINCIPAL_INVESTIGATOR) |
| Discovery Clinical Trials | Pflugerville | Texas | 78660-3015 | Brian K MacGillivray (PRINCIPAL_INVESTIGATOR) |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | - |
| University of Texas Health Science Ctr | San Antonio | Texas | 78229-3900 | William Murff Carolina Solis-Herrera (PRINCIPAL_INVESTIGATOR) |
| Javara Research | Alexandria | Virginia | 22311 | Nicole Sandiford Amine Segueni (PRINCIPAL_INVESTIGATOR) |
| Javara Research | Alexandria | Virginia | 22311 | Kiara McFarland Head Aslam Khan (PRINCIPAL_INVESTIGATOR) |
| Javara Research | Alexandria | Virginia | 22311 | Aimee Kaczorowski Monique Langston (PRINCIPAL_INVESTIGATOR) |
| Javara Research | Alexandria | Virginia | 22311 | Aarika Oeleis Benjamin Marcum (PRINCIPAL_INVESTIGATOR) |
| Virginia Heart | Falls Church | Virginia | 22042 | Tariq Haddad (PRINCIPAL_INVESTIGATOR) |
| Heart Care Associates P C | Hopewell | Virginia | 23860 | Kamlesh Dave (PRINCIPAL_INVESTIGATOR) |
| Dominion Medical Associates | Richmond | Virginia | 23219 | - |
| Vcu Health | Richmond | Virginia | 23298 | Joshua West Phillip Duncan (PRINCIPAL_INVESTIGATOR) |
| University of Washington | Seattle | Washington | 98195 | Daniel Isquith Francis Kim (PRINCIPAL_INVESTIGATOR) |
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