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Pelacarsen Roll-over Extension Program

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing
    • Trial sites reduced: 97 → 89 locations
    • Eligibility criteria expanded, about 6 words
  2. Site details revised at 8 of 97 sitesv8
  3. Study sites revised (97)v7
  4. Site details revised at 7 of 97 sitesv6
  5. Study sites: 95 to 97v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Dec 31, 2027 to Dec 8, 2030
    • Enrollment target: 600 to 599
    • Study sites: 25 to 95
    • Study completion date: Jan 3, 2028 to Dec 8, 2030
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 25
    • Start date changed from estimate of May 20, 2025 to May 19, 2025
    v3
  3. Study title shortened, about 1 wordv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
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Heart Disease
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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). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.
Trial Details
NCT Number NCT06875973
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Atherosclerotic Cardiovascular Disease
Related terms Atherosclerosis
Enrollment 599 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov