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NCT01516879 · ClinicalTrials.gov registry record · Phase 3

Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
905
Enrollment target

NCT01516879 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 905 participants.

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The verdict

NCT01516879, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
905 participants
Enrollment target

Study Summary

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Interventions

  • BIOLOGICAL Placebo
  • DRUG Ezetimibe
  • DRUG Atorvastatin
  • OTHER Diet Only
  • BIOLOGICAL Evolocumab

Trial Details

FieldValue
Enrollment Target 905 participants
Start Date 2012-01-05
Est. Completion 2013-10-14
Phase Phase 3

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT01516879

The ClinicalTrials.gov registry entry for NCT01516879 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 905 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01516879 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01516879 about?

NCT01516879 is a clinical study titled "Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study". To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

What is the current status of trial NCT01516879?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 905 participants. The study started on 2012-01-05. Estimated completion is 2013-10-14.

What interventions are being tested in trial NCT01516879?

The interventions under investigation include: Placebo (BIOLOGICAL), Ezetimibe (DRUG), Atorvastatin (DRUG), Diet Only (OTHER), Evolocumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01516879?

This trial is sponsored by Amgen, which has 558 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.