Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2025-05-19
2028-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pelacarsen (TQJ230)
open-label pelacarsen 80mg
Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Interventions
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Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have completed the parent study and received the assigned study treatment at the time of its completion
Exclusion Criteria
* Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
* Participants who are receiving another investigational drug or device before the open-label treatment period
* Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Parkway Medical Center
Birmingham, Alabama, United States
National Heart Institute
Beverly Hills, California, United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States
Proactive Clinical Research
Fort Lauderdale, Florida, United States
National Research Institute
Hialeah, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, United States
Cardiovascular Associates Research
Covington, Louisiana, United States
Southern Clin Research Clinic
Zachary, Louisiana, United States
Anderson Medical Research
Ft. Washington, Maryland, United States
Capitol Cardiology Associates
Lanham, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Aa Mrc Llc
Flint, Michigan, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, United States
North Hills Medical Research Inc
Bedford, Texas, United States
Angiocardiac Care of Texas PA
Houston, Texas, United States
Biopharma Informatic LLC
Houston, Texas, United States
Biopharma Informatic LLC
Houston, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Javara Research
Alexandria, Virginia, United States
Virginia Heart
Falls Church, Virginia, United States
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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CTQJ230A12305B
Identifier Type: -
Identifier Source: org_study_id
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