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NCT01380730 · ClinicalTrials.gov registry record · Phase 2

LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

A Phase 2 study of Hyperlipidemia, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
631
Enrollment target
20
Study locations

NCT01380730 is a Phase 2 study of Hyperlipidemia that has completed, run by Amgen. The registered enrollment target is 631 participants, above the 390-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT01380730, a Phase 2 study of Hyperlipidemia, has completed, sponsored by Amgen.

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

Study Summary

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

Conditions Studied

Hyperlipidemia

Interventions

  • BIOLOGICAL Evolocumab
  • OTHER Placebo to Evolocumab

Study Locations (20)

Florida

  • Research Site - Daytona Beach
  • Research Site - Green Cove Springs
  • Research Site - Melbourne
  • Research Site - Miami
  • Research Site - Miami
  • Research Site - Port Charlotte

California

  • Research Site - Anaheim
  • Research Site - Carmichael
  • Research Site - Newport Beach
  • Research Site - Roseville
  • Research Site - Westlake Village

Indiana

  • Research Site - Hammond
  • Research Site - Indianapolis
  • Research Site - Valparaiso

Colorado

  • Research Site - Colorado Springs
  • Research Site - Littleton

Alabama

  • Research Site - Birmingham

Arizona

  • Research Site - Tucson

Arkansas

  • Research Site - Malvern

Illinois

  • Research Site - Peoria

Trial Details

FieldValue
Enrollment Target 631 participants
Start Date 2011-07-01
Est. Completion 2012-04-05
Phase Phase 2

Sponsor

Amgen

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01380730

The ClinicalTrials.gov registry entry for NCT01380730 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 631 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 390-participant average among 35 other Hyperlipidemia trials with a reported enrollment target (62% higher). 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 2 interventions - of which Evolocumab is the first listed.

NCT01380730 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Indiana.

Frequently Asked Questions

What is clinical trial NCT01380730 about?

NCT01380730 is a clinical study titled "LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy". To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

What is the current status of trial NCT01380730?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 631 participants. The study started on 2011-07-01. Estimated completion is 2012-04-05.

What conditions does trial NCT01380730 study?

This clinical trial studies the following conditions: Hyperlipidemia.

What interventions are being tested in trial NCT01380730?

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

Who is sponsoring clinical trial NCT01380730?

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

Where is trial NCT01380730 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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.