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NCT05030428 · ClinicalTrials.gov registry record · Phase 3

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

A Phase 3 study of Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
17,004
Enrollment target
20
Study locations

NCT05030428 is a Phase 3 study of Atherosclerotic Cardiovascular Disease that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 17,004 participants, above the 6,758-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (152% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT05030428, a Phase 3 study of Atherosclerotic Cardiovascular Disease, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
17,004 participants
Enrollment target
20
Study locations

Study Summary

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Conditions Studied

Atherosclerotic Cardiovascular Disease

Interventions

  • DRUG Placebo
  • DRUG Inclisiran sodium 300 mg

Study Locations (20)

California

  • Central Cardiology Medical Center - Bakersfield
  • Alliance Clinical - Canoga Park
  • Inland Psychiatric Medical Group - Chino
  • John Muir Physician Network Clinical Research Center - Concord
  • Triallogix - Fullerton
  • Diabetes Lipid Management Center - Huntington Beach
  • University of Calif Irvine Med Cntr - Irvine
  • UC San Diego Health - La Jolla

Arizona

  • Mercy Gilbert Medical Center - Gilbert
  • Cardiovascular Associates of Mesa - Mesa
  • Elite Clinical Studies - Phoenix
  • HonorHealth Heart Group Deer Valley - Scottsdale
  • Clinical Research Inst of Arizona - Sun City West
  • Pima Heart And Vascular Clin Rch - Tucson

Alabama

  • UAB St Vincents - Birmingham
  • Eastern Shore Research Institute - Fairhope
  • G and L Research LLC - Foley

Arkansas

  • ARcare Center for Clinical Research - Little Rock
  • Arkansas Clinical Research - Little Rock

Alaska

  • Alaska Heart and Vascular - Anchorage

Trial Details

FieldValue
Enrollment Target 17,004 participants
Start Date 2021-11-23
Est. Completion 2027-10-13
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05030428

The ClinicalTrials.gov registry entry for NCT05030428 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 17,004 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 6,758-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (152% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05030428 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT05030428 about?

NCT05030428 is a clinical study titled "Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease". Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

What is the current status of trial NCT05030428?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 17,004 participants. The study started on 2021-11-23. Estimated completion is 2027-10-13.

What conditions does trial NCT05030428 study?

This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease.

What interventions are being tested in trial NCT05030428?

The interventions under investigation include: Placebo (DRUG), Inclisiran sodium 300 mg (DRUG).

Who is sponsoring clinical trial NCT05030428?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05030428 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.