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NCT05646381 · ClinicalTrials.gov registry record · Phase 2
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
A Phase 2 study of Aortic Stenosis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 502
- Enrollment target
- 20
- Study locations
NCT05646381: Recruiting Phase 2 study of Aortic Stenosis, sponsored by Novartis Pharmaceuticals.
NCT05646381 is a Phase 2 study of Aortic Stenosis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 502 participants, below the 1,343-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05646381, a Phase 2 study of Aortic Stenosis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 502 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
Primary Outcome
To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
Conditions Studied
Interventions
- DRUG Pelacarsen (TQJ230) 80mg
- DRUG Matching placebo
Study Locations (20)
California
- Cardiovascular Res Found - Beverly Hills
- National Heart Institute - Beverly Hills
- Flourish Clinical Resrch Covin - Covina
- Valley Clinical Trials - Northridge
- Stanford University Medical Center - Palo Alto
- University Of California San Diego - San Diego
- UC San Francisco Medical Center - San Francisco
Florida
- Excel Medical Clinical Trials LLC - Boca Raton
- Nova Clinical Research LLC - Bradenton
- Flourish Res Acq LLC North Miami - Miami
- Inpatient Research Clinical LLC - Miami Lakes
- Advanced Research for Health Improvement LLC - Naples
Massachusetts
- Tufts Medical Center - Boston
- Massachusetts General Hospital - Boston
- Massachusetts General Hospital - Boston
- Brigham and Womens Hosp Harvard Med School - Boston
- Brigham and Womens Hosp Harvard Med School - Boston
Alabama
- Heart Center Research Llc - Huntsville
Kansas
- Midwest Heart and Vascular Spec - Overland Park
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2030-03-12 |
| Phase | Phase 2 |
What NCT05646381 shows while recruiting
NCT05646381 is an interventional study that assigns participants to a tested intervention. The registered 502 participants enrollment target is mid-sized for trials with a published cap, below the 1,343-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Aortic Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Pelacarsen (TQJ230) 80mg is the first listed.
NCT05646381 names 20 study sites across 6 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05646381 about?
NCT05646381 is a clinical study titled "A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis". The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
What is the current status of trial NCT05646381?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 502 participants. The study started on 2024-03-07. Estimated completion is 2030-03-12.
What conditions does trial NCT05646381 study?
This clinical trial studies the following conditions: Aortic Stenosis.
What interventions are being tested in trial NCT05646381?
The interventions under investigation include: Pelacarsen (TQJ230) 80mg (DRUG), Matching placebo (DRUG).
Who is sponsoring clinical trial NCT05646381?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05646381 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05646381's enrollment target sits among peer trials
502 10th of 26 higher than 17 of 26 other Aortic Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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