An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
Part of paid clinical trials in Andalusia, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07517263
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Cardiovascular Disease and Lipoprotein(a)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pelacarsen (TQJ230) — DRUGpelacarsen 80mg s.c. monthly
Study Details
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).
Key Dates
- Start date
- May 11, 2026
- Status verified
- Jun 2026
- Primary completion
- Jan 9, 2030
- Completion
- Jan 9, 2030
Study Design
- Enrollment
- 5,700 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Pelacarsen (TQJ230)open-label pelacarsen 80mg
Primary Outcome Measure
Number of participants with Adverse events [ Time Frame: Up to 36 months ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (115)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| SEC Clinical Research LLC | Andalusia | Alabama | 36420 | Andreas Muench (PRINCIPAL_INVESTIGATOR) |
| Heart Center Research Llc | Huntsville | Alabama | 35801 | Vernon R Hunter (PRINCIPAL_INVESTIGATOR) |
| Mobile Heart Specialists | Mobile | Alabama | 36608 | Christopher S Brown (PRINCIPAL_INVESTIGATOR) |
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | Nabil Dib (PRINCIPAL_INVESTIGATOR) |
| Clinical Research Inst of Arizona | Sun City West | Arizona | 85375 | Jalal Abbas (PRINCIPAL_INVESTIGATOR) |
| Eclipse Clinical Research | Tucson | Arizona | 85745 | Eve Shapiro (PRINCIPAL_INVESTIGATOR) |
| Cardiology and Medicine Clinic PA | Little Rock | Arkansas | 72204 | Joe L Hargrove (PRINCIPAL_INVESTIGATOR) |
| Cardiovascular Res Found | Beverly Hills | California | 90210 | Ronald P Karlsberg (PRINCIPAL_INVESTIGATOR) |
| National Heart Institute | Beverly Hills | California | 90211 | Norman Lepor (PRINCIPAL_INVESTIGATOR) |
| Valley Clinical Trials Inc | Covina | California | 91723 | Sarita Garcia Masoud Azizad (PRINCIPAL_INVESTIGATOR) |
| University of Calif Irvine Med Cntr | Irvine | California | 92660 | Ailin Barseghian El-Farra (PRINCIPAL_INVESTIGATOR) |
| Keck Medical Center USC | Los Angeles | California | 90033 | Jasbeth Almanza Parveen Garg (PRINCIPAL_INVESTIGATOR) |
| Valley Clinical Trials | Northridge | California | 91325 | Mehrdad Ariani (PRINCIPAL_INVESTIGATOR) |
| Stanford University Medical Center | Palo Alto | California | 94304 | Abha Khandelwal (PRINCIPAL_INVESTIGATOR) |
| UCSF | San Francisco | California | 94115 | Eveline O Stock (PRINCIPAL_INVESTIGATOR) |
| Helping Hands Medical Associates INC | Santa Ana | California | 92704 | Alan Charles Schwartz (PRINCIPAL_INVESTIGATOR) |
| Manshadi Heart Institute | Stockton | California | 95204 | Delaina Sanguinetti Ramin Manshadi (PRINCIPAL_INVESTIGATOR) |
| Interv Cardiology Med Grp | West Hills | California | 91307 | Farhad Rafii (PRINCIPAL_INVESTIGATOR) |
| Univ Of Color Anschutz Med Center | Aurora | Colorado | 80045 | David Saxon (PRINCIPAL_INVESTIGATOR) |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | Adam Schussheim (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital | Hartford | Connecticut | 06102 | Antonio Fernandez (PRINCIPAL_INVESTIGATOR) |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | Ashish Adlakha (PRINCIPAL_INVESTIGATOR) |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | 33434 | Rasha Youssef (PRINCIPAL_INVESTIGATOR) |
| Bay Area Cardiology Assoc | Brandon | Florida | 33511 | Ranchhod Khant (PRINCIPAL_INVESTIGATOR) |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | Michael J Koren (PRINCIPAL_INVESTIGATOR) |
| Advanced Research for Health Improvement LLC | Naples | Florida | 34102 | Julian Javier (PRINCIPAL_INVESTIGATOR) |
| Peace River Cardiovascular Center | Port Charlotte | Florida | 33952 | David Allan Hotchkiss (PRINCIPAL_INVESTIGATOR) |
| Progressive Medical Research | Port Orange | Florida | 32127 | Loria Jackie Boucher Alexander J White (PRINCIPAL_INVESTIGATOR) |
| East Coast Inst for Research LLC | Saint Augustine | Florida | 32086 | Ferris George (PRINCIPAL_INVESTIGATOR) |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | 33449 | Neerav Suresh Shah (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30322 | Arshed Quyyumi (PRINCIPAL_INVESTIGATOR) |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | Joseph Miller (PRINCIPAL_INVESTIGATOR) |
| Cardiovascular Consultants of S GA | Thomasville | Georgia | 31792 | Christopher Daniels (PRINCIPAL_INVESTIGATOR) |
| Rush University Medical Center | Chicago | Illinois | 60612 | Annabelle Volgman (PRINCIPAL_INVESTIGATOR) |
| Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 4800 | Julie Clary (PRINCIPAL_INVESTIGATOR) |
| Uni Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | Marcelo Correia (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | Patrick M Moriarty (PRINCIPAL_INVESTIGATOR) |
| Cotton O Neil Clinical Res Center | Topeka | Kansas | 66606 | Michael Cox (PRINCIPAL_INVESTIGATOR) |
| Cardiovascular Associates Research | Covington | Louisiana | 70433 | Dale Presser (PRINCIPAL_INVESTIGATOR) |
| Louisiana Heart Center Research | Covington | Louisiana | 70433 | Frank Voelker (PRINCIPAL_INVESTIGATOR) |
| Louisiana Heart Center Research | Covington | Louisiana | 70433 | Bruce J Iteld (PRINCIPAL_INVESTIGATOR) |
| CV Institute of the South | Houma | Louisiana | 70360 | Peter Fail (PRINCIPAL_INVESTIGATOR) |
| Horizon Research Grp | Lafayette | Louisiana | 70501 | Randall Miller (PRINCIPAL_INVESTIGATOR) |
| Omega Clinical Research | Metairie | Louisiana | 70006 | Tuan-Huy Tran (PRINCIPAL_INVESTIGATOR) |
| Tulane Center for Clinical Research | New Orleans | Louisiana | 70112 | Keith C Ferdinand (PRINCIPAL_INVESTIGATOR) |
| CV Ins of the South | Opelousas | Louisiana | 70570 | Siby George Ayalloore (PRINCIPAL_INVESTIGATOR) |
| Grace Research Llc | Shreveport | Louisiana | 71105 | Anil Chhabra (PRINCIPAL_INVESTIGATOR) |
| Louisiana Heart Center Research | Slidell | Louisiana | 70458 | Marc Bernstein (PRINCIPAL_INVESTIGATOR) |
| Southern Clinical Research | Zachary | Louisiana | 70791 | Ernest Thompson (PRINCIPAL_INVESTIGATOR) |
| Maine Health Cardiology | Scarborough | Maine | 04074 | Edward Teufel (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins Univ School of Med | Baltimore | Maryland | 21287 | Christine McLeod Thorsten Leucker (PRINCIPAL_INVESTIGATOR) |
| Sinai Ct for Throm Res and Drug Dev | Baltimore | Maryland | 21209 | Paul Gurbel (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins University | Columbia | Maryland | 21044 | Tanya Burley Daniel Kim (PRINCIPAL_INVESTIGATOR) |
| Anderson Medical Research | Ft. Washington | Maryland | 20744 | Ann-Marie Cobb Felton Anderson (PRINCIPAL_INVESTIGATOR) |
| Adventist HealthCare Shady Grove Medical Center | Rockville | Maryland | 20850 | Michael Chen (PRINCIPAL_INVESTIGATOR) |
| Brigham and Womens Hosp Harvard Med School | Boston | Massachusetts | 02115 | Ron Blankstein (PRINCIPAL_INVESTIGATOR) |
| MGH | Boston | Massachusetts | 02114 2696 | Katherine Ward Maria T Vivaldi (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Khaled Abdul-Nour (PRINCIPAL_INVESTIGATOR) |
| Wayne State University | Detroit | Michigan | 48201 | Brian J O Neil (PRINCIPAL_INVESTIGATOR) |
| AA Medical Research Center | Flint | Michigan | 48504 | Ahmed A Arif (PRINCIPAL_INVESTIGATOR) |
| Western Michigan University | Kalamazoo | Michigan | 49008 | Debbi Hotchkiss Vishal Gupta (PRINCIPAL_INVESTIGATOR) |
| McLaren Ctr Research Innovation | Petoskey | Michigan | 49770 | Joel Engel (PRINCIPAL_INVESTIGATOR) |
| Central Michigan University | Saginaw | Michigan | 48601 | Peter G Fattal (PRINCIPAL_INVESTIGATOR) |
| Metro Health Univ of MI Health | Wyoming | Michigan | 49519 | Rony Gorges (PRINCIPAL_INVESTIGATOR) |
| Saint Johns Hospital | Maplewood | Minnesota | 55109 | Les B Forgosh (PRINCIPAL_INVESTIGATOR) |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | Thomas Knickelbine (PRINCIPAL_INVESTIGATOR) |
| University Of Minnesota | Minneapolis | Minnesota | 55455 | Daniel Duprez (PRINCIPAL_INVESTIGATOR) |
| Belzoni Clinical Research | Belzoni | Mississippi | 39038 | Sidney Carlton Gorton (PRINCIPAL_INVESTIGATOR) |
| Stern Cardiovascular Foundation Inc | Southaven | Mississippi | 38671 | Dharmesh Patel (PRINCIPAL_INVESTIGATOR) |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | Timothy Smith (PRINCIPAL_INVESTIGATOR) |
| Washington Univ School Of Medicine | St Louis | Missouri | 63110 | Anne Goldberg (PRINCIPAL_INVESTIGATOR) |
| Quality Clinical Research | Omaha | Nebraska | 68114 | John Hallgren (PRINCIPAL_INVESTIGATOR) |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | Jonathan C Waltman (PRINCIPAL_INVESTIGATOR) |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | Joel Landzberg (PRINCIPAL_INVESTIGATOR) |
| Overlook Medical Center | Summit | New Jersey | 07901 | Rosmery Montesino Robert Fishberg (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | Manhasset | New York | 11030 | Bani Azari (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Med at Mt Sinai | New York | New York | 10029 | Robert Rosenson (PRINCIPAL_INVESTIGATOR) |
| Lenox Hill Hospital | New York | New York | 43210 | Lauren Senia Eugenia Gianos (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medical Center | New York | New York | 10021 | Samuel Kim (PRINCIPAL_INVESTIGATOR) |
| Northwell Health Physician Peconic | Riverhead | New York | 11901 | Sean Donahoe (PRINCIPAL_INVESTIGATOR) |
| Novant Health Heart Vas Inst | Charlotte | North Carolina | 28204 | Anish Vani (PRINCIPAL_INVESTIGATOR) |
| Medication Management LLC | Greensboro | North Carolina | 27405 | James Franklin (PRINCIPAL_INVESTIGATOR) |
| Accellacare US Inc | Raleigh | North Carolina | 27609 | John Rubino (PRINCIPAL_INVESTIGATOR) |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Herman Barrett Cheek (PRINCIPAL_INVESTIGATOR) |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Michael Shapiro (PRINCIPAL_INVESTIGATOR) |
| Aultman Hospital | Canton | Ohio | 44710 | Ramana Podugu (PRINCIPAL_INVESTIGATOR) |
| Lindner Ctr At The Christ Hosp | Cincinnati | Ohio | 45219 | Dean J Kereiakes (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Dennis C. Bruemmer (PRINCIPAL_INVESTIGATOR) |
| Ohio State University | Columbus | Ohio | 43210 | Wesley Milks (PRINCIPAL_INVESTIGATOR) |
| Rama Research LLC | Marion | Ohio | 43302 | Bhola Rama (PRINCIPAL_INVESTIGATOR) |
| Lancaster General Health | Lancaster | Pennsylvania | 17603 | Kay Knepper Marjan U Mujib (PRINCIPAL_INVESTIGATOR) |
| Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | Archna Bajaj (PRINCIPAL_INVESTIGATOR) |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | Paul Grena (PRINCIPAL_INVESTIGATOR) |
| Monument Health Clinical Research | Rapid City | South Dakota | 57701 | Stephen Wasemiller (PRINCIPAL_INVESTIGATOR) |
| The Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | Frank Augustus McGrew (PRINCIPAL_INVESTIGATOR) |
| Apex Cardiology Research Associates of Jackson | Jackson | Tennessee | 38301 | Mohsin Alhaddad (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt Univ Medi Cen | Nashville | Tennessee | 37232 | MacRae Linton (PRINCIPAL_INVESTIGATOR) |
| Cardiovascular Res of Knoxville LLC | Powell | Tennessee | 37849 | Charles B Treasure (PRINCIPAL_INVESTIGATOR) |
| North Texas Endocrine Center | Dallas | Texas | 75231 | Peter Bressler (PRINCIPAL_INVESTIGATOR) |
| Soltero Cardiovascular Research Center | Dallas | Texas | 75226 | Cara East (PRINCIPAL_INVESTIGATOR) |
| SW Family Medicine Associates | Dallas | Texas | 75235 | Chrisette Dharma (PRINCIPAL_INVESTIGATOR) |
| Baylor College Of Medicine | Houston | Texas | 77030 | Christie M Ballantyne (PRINCIPAL_INVESTIGATOR) |
| Grace Research | Marshall | Texas | 75670 | William Eaves (PRINCIPAL_INVESTIGATOR) |
| Northwest Houston Clinical Research PLLC | Tomball | Texas | 77375 | Shamaila Aslam (PRINCIPAL_INVESTIGATOR) |
| Progressive Clinical Research | Bountiful | Utah | 84010 | Joshua Oaks (PRINCIPAL_INVESTIGATOR) |
| Intermountain Medical Center | Murray | Utah | 84107 | Jeffrey Anderson (PRINCIPAL_INVESTIGATOR) |
| The University of Utah | Salt Lake City | Utah | 84132-0001 | Aaron Shoskes (PRINCIPAL_INVESTIGATOR) |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Joanne Wotring Jared Spitz (PRINCIPAL_INVESTIGATOR) |
| Virginia Heart | Falls Church | Virginia | 22042 | Tariq Haddad (PRINCIPAL_INVESTIGATOR) |
| Carient Heart and Vascular | Manassas | Virginia | 20109 | Vikram Prasanna (PRINCIPAL_INVESTIGATOR) |
| Dominion Medical Associates | Richmond | Virginia | 23219 | Richard A Jackson (PRINCIPAL_INVESTIGATOR) |
| Harborview Medical Center | Seattle | Washington | 98104 | Francis Kim (PRINCIPAL_INVESTIGATOR) |
| Swedish Medical Center-Cardiovascular Research | Seattle | Washington | 98122 | John Petersen II (PRINCIPAL_INVESTIGATOR) |
| Univ of Washington Medical Center | Seattle | Washington | 98195 | Kelley Branch (PRINCIPAL_INVESTIGATOR) |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | Sudarshan Balla (PRINCIPAL_INVESTIGATOR) |