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NCT05739383 · ClinicalTrials.gov registry record · Phase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
A Phase 3 study of Primary Prevention of Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 14,078
- Enrollment target
- 20
- Study locations
NCT05739383 is a Phase 3 study of Primary Prevention of Atherosclerotic Cardiovascular Disease that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 14,078 participants. The trial reports 20 study locations across 3 states.
The verdict
NCT05739383, a Phase 3 study of Primary Prevention of Atherosclerotic Cardiovascular Disease, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 14,078 participants
- Enrollment target
- 20
- Study locations
Study Summary
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Conditions Studied
Interventions
- DRUG Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- DRUG Placebo in 1.5ml
Study Locations (20)
Alabama
- Central Alabama Research - Birmingham
- UAB St Vincents - Birmingham
- Eastern Shore Research Institute - Fairhope
- G and L Research LLC - Foley
- Longwood Research - Huntsville
- CB Flock Corporation - Mobile
- Mobile Heart Specialists - Mobile
- The Center for Clinical Trials - Saraland
Arizona
- Synexus - Glendale
- Lenzmeier Family Practice - Glendale
- Avacare Center for Dermatology - Phoenix
- Clinical Research Inst of Arizona - Sun City West
- Clinical Research Advantage Fiel Family and Sports Med, PC - Tempe
- Synexus Clinical Research US Inc - Tucson
California
- Cardiovascular Res Found - Beverly Hills
- National Heart Institute - Beverly Hills
- Alliance Clinical - Canoga Park
- Inland Psychiatric Medical Group - Chino
- Valley Clinical Trials Inc - Covina
- Keck Medical Center USC - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,078 participants |
| Start Date | 2023-03-09 |
| Est. Completion | 2029-04-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05739383
The ClinicalTrials.gov registry entry for NCT05739383 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 14,078 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Prevention of Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL is the first listed.
NCT05739383 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Alabama, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05739383 about?
NCT05739383 is a clinical study titled "A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.". CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic card...
What is the current status of trial NCT05739383?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 14,078 participants. The study started on 2023-03-09. Estimated completion is 2029-04-16.
What conditions does trial NCT05739383 study?
This clinical trial studies the following conditions: Primary Prevention of Atherosclerotic Cardiovascular Disease.
What interventions are being tested in trial NCT05739383?
The interventions under investigation include: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL (DRUG), Placebo in 1.5ml (DRUG).
Who is sponsoring clinical trial NCT05739383?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05739383 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.