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NCT04929249 · ClinicalTrials.gov registry record · Phase 3

A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
450
Enrollment target

NCT04929249 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 450 participants.

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The verdict

NCT04929249, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
450 participants
Enrollment target

Study Summary

The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in an atherosclerotic cardiovascular disease (ASCVD) population.

Interventions

  • DRUG Inclisiran

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2021-06-25
Est. Completion 2023-09-15
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT04929249

The ClinicalTrials.gov registry entry for NCT04929249 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 450 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 0 conditions, and to 1 intervention - of which Inclisiran is the first listed.

NCT04929249 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04929249 about?

NCT04929249 is a clinical study titled "A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)". The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in an at...

What is the current status of trial NCT04929249?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2021-06-25. Estimated completion is 2023-09-15.

What interventions are being tested in trial NCT04929249?

The interventions under investigation include: Inclisiran (DRUG).

Who is sponsoring clinical trial NCT04929249?

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

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

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.