An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
Purpose
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).
Condition
- Cardiovascular Disease and Lipoprotein(a)
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open-label extension (OLE) study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Open label study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Pelacarsen (TQJ230) |
open-label pelacarsen 80mg |
|
Recruiting Locations
SEC Clinical Research LLC
Andalusia, Alabama 36420
Andalusia, Alabama 36420
Heart Center Research Llc
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Mobile Heart Specialists
Mobile, Alabama 36608
Mobile, Alabama 36608
Mercy Gilbert Medical Center
Gilbert, Arizona 85297
Gilbert, Arizona 85297
Clinical Research Inst of Arizona
Sun City West, Arizona 85375
Sun City West, Arizona 85375
Eclipse Clinical Research
Tucson, Arizona 85745
Tucson, Arizona 85745
Cardiovascular Res Found
Beverly Hills, California 90210
Beverly Hills, California 90210
National Heart Institute
Beverly Hills, California 90211
Beverly Hills, California 90211
Valley Clinical Trials Inc
Covina, California 91723
Covina, California 91723
Keck Medical Center USC
Los Angeles, California 90033
Los Angeles, California 90033
Helping Hands Medical Associates INC
Santa Ana, California 92704
Santa Ana, California 92704
Manshadi Heart Institute
Stockton, California 95204
Stockton, California 95204
Interv Cardiology Med Grp
West Hills, California 91307
West Hills, California 91307
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Chase Medical Research LLC
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
Excel Medical Clinical Trials LLC
Boca Raton, Florida 33434
Boca Raton, Florida 33434
Bay Area Cardiology Assoc
Brandon, Florida 33511
Brandon, Florida 33511
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Advanced Research for Health Improvement LLC
Naples, Florida 34102
Naples, Florida 34102
Peace River Cardiovascular Center
Port Charlotte, Florida 33952
Port Charlotte, Florida 33952
Progressive Medical Research
Port Orange, Florida 32127
Port Orange, Florida 32127
East Coast Inst for Research LLC
Saint Augustine, Florida 32086
Saint Augustine, Florida 32086
Cardiology Partners Clinical Research Institute
Wellington, Florida 33449
Wellington, Florida 33449
Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Cardiovascular Consultants of S GA
Thomasville, Georgia 31792
Thomasville, Georgia 31792
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
Krannert Institute of Cardiology
Indianapolis, Indiana 46202 4800
Indianapolis, Indiana 46202 4800
Uni Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Kansas Hospital
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Cotton O Neil Clinical Res Center
Topeka, Kansas 66606
Topeka, Kansas 66606
Cardiovascular Associates Research
Covington, Louisiana 70433
Covington, Louisiana 70433
Louisiana Heart Center Research
Covington, Louisiana 70433
Covington, Louisiana 70433
Louisiana Heart Center Research
Covington, Louisiana 70433
Covington, Louisiana 70433
Horizon Research Grp
Lafayette, Louisiana 70501
Lafayette, Louisiana 70501
Omega Clinical Research
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Tulane Center for Clinical Research
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
CV Ins of the South
Opelousas, Louisiana 70570
Opelousas, Louisiana 70570
Grace Research Llc
Shreveport, Louisiana 71105
Shreveport, Louisiana 71105
Southern Clinical Research
Zachary, Louisiana 70791
Zachary, Louisiana 70791
Sinai Ct for Throm Res and Drug Dev
Baltimore, Maryland 21209
Baltimore, Maryland 21209
Anderson Medical Research
Ft. Washington, Maryland 20744
Ft. Washington, Maryland 20744
Adventist HealthCare Shady Grove Medical Center
Rockville, Maryland 20850
Rockville, Maryland 20850
Wayne State University
Detroit, Michigan 48201
Detroit, Michigan 48201
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
AA Medical Research Center
Flint, Michigan 48504
Flint, Michigan 48504
Western Michigan University
Kalamazoo, Michigan 49008
Kalamazoo, Michigan 49008
McLaren Ctr Research Innovation
Petoskey, Michigan 49770
Petoskey, Michigan 49770
Metro Health Univ of MI Health
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Saint Johns Hospital
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
University Of Minnesota
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
Stern Cardiovascular Foundation Inc
Southaven, Mississippi 38671
Southaven, Mississippi 38671
StudyMetrix Research
City of Saint Peters, Missouri 63303
City of Saint Peters, Missouri 63303
Quality Clinical Research
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Overlook Medical Center
Summit, New Jersey 07901
Summit, New Jersey 07901
Northwell Health
Manhasset, New York 11030
Manhasset, New York 11030
Weill Cornell Medical Center
New York, New York 10021
New York, New York 10021
Northwell Health Physician Peconic
Riverhead, New York 11901
Riverhead, New York 11901
Novant Health Heart Vas Inst
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Medication Management LLC
Greensboro, North Carolina 27405
Greensboro, North Carolina 27405
Accellacare US Inc
Raleigh, North Carolina 27609
Raleigh, North Carolina 27609
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Aultman Hospital
Canton, Ohio 44710
Canton, Ohio 44710
Lindner Ctr At The Christ Hosp
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Lancaster General Health
Lancaster, Pennsylvania 17603
Lancaster, Pennsylvania 17603
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania 19067
Yardley, Pennsylvania 19067
Monument Health Clinical Research
Rapid City, South Dakota 57701
Rapid City, South Dakota 57701
The Stern Cardiovascular Foundation
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee 38301
Jackson, Tennessee 38301
Vanderbilt Univ Medi Cen
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Cardiovascular Res of Knoxville LLC
Powell, Tennessee 37849
Powell, Tennessee 37849
Soltero Cardiovascular Research Center
Dallas, Texas 75226
Dallas, Texas 75226
North Texas Endocrine Center
Dallas, Texas 75231
Dallas, Texas 75231
SW Family Medicine Associates
Dallas, Texas 75235
Dallas, Texas 75235
Grace Research
Marshall, Texas 75670
Marshall, Texas 75670
Northwest Houston Clinical Research PLLC
Tomball, Texas 77375
Tomball, Texas 77375
Progressive Clinical Research
Bountiful, Utah 84010
Bountiful, Utah 84010
Intermountain Medical Center
Murray, Utah 84107
Murray, Utah 84107
The University of Utah
Salt Lake City, Utah 84132-0001
Salt Lake City, Utah 84132-0001
Inova Fairfax Hospital
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Virginia Heart
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Carient Heart and Vascular
Manassas, Virginia 20109
Manassas, Virginia 20109
Dominion Medical Associates
Richmond, Virginia 23219
Richmond, Virginia 23219
Harborview Medical Center
Seattle, Washington 98104
Seattle, Washington 98104
Swedish Medical Center-Cardiovascular Research
Seattle, Washington 98122
Seattle, Washington 98122
West Virginia University Hospital
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Research and Cardiovascular Corp
Ponce, Puerto Rico 00717-1322
Ponce, Puerto Rico 00717-1322
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).