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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).
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelacarsen (TQJ230) | Experimental | open-label pelacarsen 80mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelacarsen (TQJ230) | Drug | pelacarsen 80mg s.c. monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events (AEs) or serious adverse events (SAEs) | Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study | Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels | Baseline of the core study, Month 3, 12, 24, 36, 48 |
| Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Recruiting | Birmingham | Alabama | 35215 | United States |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Rollover extension program (REP)
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Open label study
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Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels |
| Baseline of the REP study, Month 3, 12, 24, 36, 48 |
| Cardiology and Medicine Clinic PA | Recruiting | Little Rock | Arkansas | 72204 | United States |
|
| National Heart Institute | Recruiting | Beverly Hills | California | 90211 | United States |
|
| Hope Clinical Research | Recruiting | Canoga Park | California | 91303 | United States |
|
| Valley Clinical Trials Inc | Recruiting | Covina | California | 91723 | United States |
|
| NICRs Research Center | Recruiting | Garden Grove | California | 92844 | United States |
|
| University of Calif Irvine Med Cntr | Recruiting | Irvine | California | 92660 | United States |
|
| Long Beach Clinical Trials | Recruiting | Long Beach | California | 90806 | United States |
|
| Angel City Research Inc | Recruiting | Los Angeles | California | 90026 | United States |
|
| California Medical Research Associates Inc | Recruiting | Northridge | California | 91324 | United States |
|
| Stanford Health Care | Recruiting | Stanford | California | 94305 | United States |
|
| Excel Medical Clinical Trials LLC | Active, not recruiting | Boca Raton | Florida | 33434 | United States |
| C and A Clinical Trials | Recruiting | Cape Coral | Florida | 33990 | United States |
|
| Proactive Clinical Research | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
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| Proactive Clinical Research | Active, not recruiting | Fort Lauderdale | Florida | 33308 | United States |
| National Research Institute | Recruiting | Hialeah | Florida | 33013 | United States |
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| Sister Life Research Inc | Recruiting | Hialeah | Florida | 33013 | United States |
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| Zenith Clinical Research | Recruiting | Hollywood | Florida | 33021 | United States |
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| Columbus Clinical Services LLC | Recruiting | Miami | Florida | 33125 | United States |
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| Finlay Medical Research | Active, not recruiting | Miami | Florida | 33126 | United States |
| Infinite Clinical Research | Recruiting | Miami | Florida | 33133 | United States |
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| International Research Associates LLC | Recruiting | Miami | Florida | 33156 | United States |
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| Baptist Health South | Recruiting | Miami | Florida | 33173 | United States |
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| A&A Research Group Inc | Recruiting | Miami | Florida | 33186 | United States |
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| Inpatient Research Clinical LLC | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| Inpatient Research Clinical LLC | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| FXM Clin Res Miramar LLC | Active, not recruiting | Miramar | Florida | 33027 | United States |
| CTMD Research | Recruiting | Palm Springs | Florida | 33406 | United States |
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| DBC Research USA | Recruiting | Pembroke Pines | Florida | 33029 | United States |
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| New Tampa Health | Recruiting | Tampa | Florida | 33603 | United States |
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| James A Haley Veterans Hospital | Recruiting | Tampa | Florida | 33612 | United States |
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| Cardiology Partners Clinical Research Institute | Recruiting | Wellington | Florida | 33449 | United States |
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| Flourish Research | Active, not recruiting | Winter Park | Florida | 32789 | United States |
| Flourish Research | Recruiting | Winter Park | Florida | 32789 | United States |
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| Morehouse School Of Medicine | Recruiting | Atlanta | Georgia | 30310 | United States |
|
| Atlanta Heart Specialists LLC | Recruiting | Tucker | Georgia | 30084 | United States |
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| Synexus Clinical Research US Inc | Active, not recruiting | Chicago | Illinois | 60602 | United States |
| Chicago Clinical Research Inst | Recruiting | Chicago | Illinois | 60607 | United States |
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| Cardiovascular Associates Research | Recruiting | Covington | Louisiana | 70433 | United States |
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| Omega Clinical Research | Recruiting | Metairie | Louisiana | 70006 | United States |
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| CV Ins of the South | Recruiting | Opelousas | Louisiana | 70570 | United States |
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| Monroe Research Llc | Recruiting | West Monroe | Louisiana | 71291 | United States |
|
| Southern Clin Research Clinic | Active, not recruiting | Zachary | Louisiana | 70791 | United States |
| Sinai Ct for Throm Res and Drug Dev | Recruiting | Baltimore | Maryland | 21209 | United States |
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| Ascension Saint Agnes Heart Care | Recruiting | Baltimore | Maryland | 21229 | United States |
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| Johns Hopkins Univ School of Med | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Metropolitan Cardiovascular Consultants Llc | Recruiting | Beltsville | Maryland | 20705 | United States |
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| Johns Hopkins University | Recruiting | Columbia | Maryland | 21044 | United States |
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| Anderson Medical Research | Active, not recruiting | Ft. Washington | Maryland | 20744 | United States |
| Capitol Cardiology Associates | Recruiting | Lanham | Maryland | 20706 | United States |
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| MD Medical Research | Recruiting | Oxon Hill | Maryland | 20745 | United States |
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| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
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| Aa Mrc Mhs | Recruiting | Flint | Michigan | 48503 | United States |
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| Aa Mrc Llc | Active, not recruiting | Flint | Michigan | 48504 | United States |
| Elite Clinical Research | Recruiting | Jackson | Mississippi | 39202 | United States |
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| Stern Cardiovascular Foundation Inc | Recruiting | Southaven | Mississippi | 38671 | United States |
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| Las Vegas Endocrinology | Recruiting | Henderson | Nevada | 89074 | United States |
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| AB Clinical Trials | Recruiting | Las Vegas | Nevada | 89119 | United States |
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| Clinical Research of South Nevada | Recruiting | Las Vegas | Nevada | 89121 | United States |
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| Robert Wood Johnson Medical School | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Overlook Medical Center | Recruiting | Summit | New Jersey | 07901 | United States |
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| Jamaica Hospital Medical Center | Recruiting | Richmond Hill | New York | 11418 | United States |
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| Monroe Biomedical Research | Recruiting | Monroe | North Carolina | 28112 | United States |
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| Alliance Medical Ministry | Recruiting | Raleigh | North Carolina | 27610 | United States |
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| NexGen Research | Recruiting | Lima | Ohio | 45801 | United States |
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| Care Access Research | Recruiting | Easton | Pennsylvania | 18045 | United States |
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| TCV Clinical Studies | Recruiting | Linwood | Pennsylvania | 19061 | United States |
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| Apex Cardiology Research Associates of Jackson | Recruiting | Jackson | Tennessee | 38301 | United States |
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| Plano Primary Care Clinic | Recruiting | Allen | Texas | 75002-3688 | United States |
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| Pharma Tex Research | Recruiting | Amarillo | Texas | 79106 | United States |
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| North Hills Medical Research Inc | Active, not recruiting | Bedford | Texas | 76021 | United States |
| SW Family Medicine Associates | Recruiting | Dallas | Texas | 75235 | United States |
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| David Turbay MD PLLC | Recruiting | El Paso | Texas | 79905 | United States |
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| Angiocardiac Care of Texas PA | Recruiting | Houston | Texas | 77025 | United States |
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| Dallas Heart and Vascular Consultants PA | Recruiting | Houston | Texas | 77084 | United States |
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| Dallas Heart and Vascular Consultants PA | Active, not recruiting | Houston | Texas | 77084 | United States |
| Dallas Heart and Vascular Consultants PA | Recruiting | Houston | Texas | 77084 | United States |
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| Epic Clinical Research | Recruiting | Lewisville | Texas | 75057 | United States |
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| The Heart Institute of East Texas | Recruiting | Lufkin | Texas | 75904 | United States |
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| Discovery Clinical Trials | Recruiting | Pflugerville | Texas | 78660-3015 | United States |
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| University of Texas Health Science Ctr | Recruiting | San Antonio | Texas | 78229-3900 | United States |
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| Clinical Trials of Texas | Active, not recruiting | San Antonio | Texas | 78229 | United States |
| Javara Research | Recruiting | Alexandria | Virginia | 22311 | United States |
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| Javara Research | Recruiting | Alexandria | Virginia | 22311 | United States |
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| Javara Research | Recruiting | Alexandria | Virginia | 22311 | United States |
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| Javara Research | Recruiting | Alexandria | Virginia | 22311 | United States |
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| Virginia Heart | Recruiting | Falls Church | Virginia | 22042 | United States |
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| Heart Care Associates P C | Recruiting | Hopewell | Virginia | 23860 | United States |
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| Dominion Medical Associates | Active, not recruiting | Richmond | Virginia | 23219 | United States |
| Vcu Health | Recruiting | Richmond | Virginia | 23298 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| Advanced Clinical Research LLC | Recruiting | Bayamón | 00959 | Puerto Rico |
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| Dr Yolanda Figueroa Private Pr | Recruiting | Humacao | 00791 | Puerto Rico |
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| CAIMED Center | Recruiting | Ponce | 00716 | Puerto Rico |
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| Research and Cardiovascular Corp | Recruiting | Ponce | 00717-1322 | Puerto Rico |
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| Latin Clinical Trial Center Inc | Recruiting | San Juan | 00909 | Puerto Rico |
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| VA Caribbean Healthcare System | Recruiting | San Juan | 00921 | Puerto Rico |
|
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000730804 | pelacarsen |
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