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NCT03399370 · ClinicalTrials.gov registry record · Phase 3

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

A Phase 3 study, sponsored by The Medicines Company.

Completed
Registry status
Phase 3
Development phase
1,561
Enrollment target

NCT03399370 is a Phase 3 study that has completed, run by The Medicines Company. The registered enrollment target is 1,561 participants.

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The verdict

NCT03399370, a Phase 3 study, has completed, sponsored by The Medicines Company.

COMPLETED
Registry status
Phase 3
Development phase
1,561 participants
Enrollment target

Study Summary

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.

Interventions

  • DRUG Placebo
  • DRUG Inclisiran Sodium

Trial Details

FieldValue
Enrollment Target 1,561 participants
Start Date 2017-12-21
Est. Completion 2019-09-17
Phase Phase 3

Sponsor

The Medicines Company

35 total trials

What the Registry Record Tells You About NCT03399370

The ClinicalTrials.gov registry entry for NCT03399370 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,561 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Medicines Company, which has 35 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03399370 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03399370 about?

NCT03399370 is a clinical study titled "Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol". This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multic...

What is the current status of trial NCT03399370?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,561 participants. The study started on 2017-12-21. Estimated completion is 2019-09-17.

What interventions are being tested in trial NCT03399370?

The interventions under investigation include: Placebo (DRUG), Inclisiran Sodium (DRUG).

Who is sponsoring clinical trial NCT03399370?

This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.

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.