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NCT01375764 · ClinicalTrials.gov registry record · Phase 2

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

A Phase 2 study of Hyperlipidemia, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
160
Enrollment target
20
Study locations

NCT01375764 is a Phase 2 study of Hyperlipidemia that has completed, run by Amgen. The registered enrollment target is 160 participants, below the 403-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT01375764, a Phase 2 study of Hyperlipidemia, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
160 participants
Enrollment target
20
Study locations

Study Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Conditions Studied

Hyperlipidemia

Interventions

  • DRUG Ezetimibe
  • BIOLOGICAL Evolocumab
  • OTHER Placebo to Evolocumab

Study Locations (20)

California

  • Research Site - Anaheim
  • Research Site - Mission Viejo
  • Research Site - Westlake Village

Georgia

  • Research Site - Atlanta
  • Research Site - Atlanta
  • Research Site - Savannah

Nevada

  • Research Site - Henderson
  • Research Site - Las Vegas

Ohio

  • Research Site - Akron
  • Research Site - Cincinnati

New South Wales

  • Research Site - Camperdown
  • Research Site - Sydney

Maine

  • Research Site - Auburn

Maryland

  • Research Site - Chevy Chase

Montana

  • Research Site - Butte

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2011-07-28
Est. Completion 2012-05-08
Phase Phase 2

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT01375764

The ClinicalTrials.gov registry entry for NCT01375764 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 403-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (60% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hyperlipidemia appearing as the primary indexed condition, and to 3 interventions - of which Ezetimibe is the first listed.

NCT01375764 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Georgia, Nevada.

Frequently Asked Questions

What is clinical trial NCT01375764 about?

NCT01375764 is a clinical study titled "Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects". The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

What is the current status of trial NCT01375764?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2011-07-28. Estimated completion is 2012-05-08.

What conditions does trial NCT01375764 study?

This clinical trial studies the following conditions: Hyperlipidemia.

What interventions are being tested in trial NCT01375764?

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

Who is sponsoring clinical trial NCT01375764?

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

Where is trial NCT01375764 being conducted?

This trial has 20 study locations across California, Georgia, Maine, Maryland, Montana. 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.