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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects With Hyperlipidemia on Stable Doses of a Statin.

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Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects With Hyperlipidemia on Stable Doses of a Statin.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Evolocumab (Primary)
  • Indications Hypercholesterolaemia; Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Amgen

Most Recent Events

  • 15 Nov 2016 Results of pooled analysis from this and other study (20080397 and 20080398) assessing pharmacokinetic-pharmacodynamic relationship of evolocumab published in the Journal of Clinical Pharmacology.
  • 21 Oct 2015 HMG-CoA-reductase-inhibitors removed from treatment as reported by ClinicalTrials.gov.
  • 27 Mar 2012 Results presented at the 61st Annual Scientific Session of the American College of Cardiology.

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