A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

Trial Profile

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jul 2017

At a glance

  • Drugs Evolocumab (Primary)
  • Indications Cardiovascular disorders; Dyslipidaemias; Hypercholesterolaemia; Hyperlipidaemia; Myocardial infarction; Stroke
  • Focus Registrational; Therapeutic Use
  • Acronyms FOURIER; PROFICIO
  • Sponsors Amgen
  • Most Recent Events

    • 27 Jul 2017 Results published in the Amgen media release.
    • 27 Jul 2017 According to an Amgen media release, based on the data from this trial, the U.S. Food and Drug Administration (FDA) has granted priority review for the supplemental Biologics License Application (sBLA) for Repatha (evolocumab). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 02 Dec 2017.
    • 18 Jul 2017 Results published in the Annals of Internal Medicine
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