Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06813911 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Study acronym: ADD-VANTAGE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Final enrollment: 246 participants (planned 340) · Study sites: 95 to 94 · Eligibility criteria expanded, about 20 words · 1 more Show 4 more changesShow less
    • Final enrollment: 246 participants (planned 340)
    • Study sites: 95 to 94
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Site details revised at 15 of 95 sitesv17
  3. Site details revised at 6 of 95 sitesv16
  4. Study sites: 96 to 95v15
  5. Trial sites expanded: 92 → 96 locationsv14
  6. Trial sites expanded: 80 → 92 locationsv13
  7. Study sites: 52 to 80 Primary completion date: Nov 5, 2027 to Feb 3, 2028 · Completion date: Dec 1, 2027 to Feb 29, 2028v12 Show 2 more changesShow less
    • Primary completion date: Nov 5, 2027 to Feb 3, 2028
    • Completion date: Dec 1, 2027 to Feb 29, 2028
  8. Study sites: 43 to 52v11
  9. Study sites: 30 to 43v10
  10. Study sites: 24 to 30v9
  11. Study sites: 18 to 24v8
  12. Study sites: 14 to 18v7
  13. Study sites: 9 to 14v6
  14. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 9 · Primary completion date: Aug 27, 2027 to Nov 5, 2027 · Completion date: Dec 17, 2027 to Dec 1, 2027 · 1 morev5 Show 4 more changesShow less
    • Study sites: 0 to 9
    • Primary completion date: Aug 27, 2027 to Nov 5, 2027
    • Completion date: Dec 17, 2027 to Dec 1, 2027
    • Start date changed from estimate of May 28, 2025 to Apr 30, 2025
  15. 2 versions Re-verified since Apr 14, 2025, no change to tracked fieldsv3-v4
  16. Study description shortened, about 46 wordsv2 See this version in full on ClinicalTrials.gov ↗
  17. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
555 trials monitored
See 31 trials at risk
Heart Disease
2,136 trials monitored
See 109 trials at risk
The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).
Trial Details
NCT Number NCT06813911
Lead Sponsor Novartis Pharmaceuticals
Conditions Atherosclerotic Cardiovascular Disease (ASCVD)
Enrollment 246 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov