An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Phase 3RecruitingNCT07517263

Novartis Pharmaceuticals5,700 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

5,700

Conditions

Cardiovascular Disease and Lipoprotein(a)

Interventions

Pelacarsen (TQJ230)DRUG

pelacarsen 80mg s.c. monthly

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (655)

Outcomes

Primary Outcomes

Number of participants with Adverse events

Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.

Time frame: Up to 36 months

Secondary Outcomes

Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline

Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the parent study will be presented

Time frame: Up to 36 months

Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline

Time frame: Up to 36 months

Cumulative number of 4P-MACE over time from OLE study baseline

Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the OLE study will be presented

Time frame: Up to 36 months

Cumulative number of 4P-MACE over time from parent study baseline

Central Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

SEC Clinical Research LLC

Andalusia, Alabama, United States

RECRUITING

Heart Center Research Llc

Huntsville, Alabama, United States

RECRUITING

Mobile Heart Specialists

Mobile, Alabama, United States

RECRUITING

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

RECRUITING

Clinical Research Inst of Arizona

Sun City West, Arizona, United States

RECRUITING

Eclipse Clinical Research

Tucson, Arizona, United States

RECRUITING

Cardiology and Medicine Clinic PA

Little Rock, Arkansas, United States

RECRUITING

Cardiovascular Res Found

Beverly Hills, California, United States

RECRUITING

National Heart Institute

Beverly Hills, California, United States

RECRUITING

Valley Clinical Trials Inc

Covina, California, United States

ACTIVE_NOT_RECRUITING

...and 645 more locations