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NCT01813422 · ClinicalTrials.gov registry record · Phase 3

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

A Phase 3 study of Hypercholesterolemia, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
970
Enrollment target
20
Study locations

NCT01813422 is a Phase 3 study of Hypercholesterolemia that has completed, run by Amgen. The registered enrollment target is 970 participants, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT01813422, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
970 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

Conditions Studied

Hypercholesterolemia

Interventions

  • DRUG Placebo
  • BIOLOGICAL Evolocumab

Study Locations (20)

California

  • Research Site - La Jolla
  • Research Site - La Jolla
  • Research Site - Long Beach
  • Research Site - Newport Beach
  • Research Site - Orange
  • Research Site - San Diego
  • Research Site - Santa Monica
  • Research Site - Torrance

Florida

  • Research Site - Atlantis
  • Research Site - Clearwater
  • Research Site - Jacksonville
  • Research Site - Jacksonville
  • Research Site - Melbourne
  • Research Site - Safety Harbor

Alabama

  • Research Site - Huntsville
  • Research Site - Mobile

Arkansas

  • Research Site - Little Rock

District of Columbia

  • Research Site - Washington D.C.

Georgia

  • Research Site - Atlanta

Indiana

  • Research Site - Hammond

Trial Details

FieldValue
Enrollment Target 970 participants
Start Date 2013-04-18
Est. Completion 2016-07-29
Phase Phase 3

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT01813422

The ClinicalTrials.gov registry entry for NCT01813422 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 970 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 801-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (21% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

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

NCT01813422 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT01813422 about?

NCT01813422 is a clinical study titled "GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound". This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

What is the current status of trial NCT01813422?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 970 participants. The study started on 2013-04-18. Estimated completion is 2016-07-29.

What conditions does trial NCT01813422 study?

This clinical trial studies the following conditions: Hypercholesterolemia.

What interventions are being tested in trial NCT01813422?

The interventions under investigation include: Placebo (DRUG), Evolocumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01813422?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01813422 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, District of Columbia, Florida. 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.