A Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a Prefilled Syringe or a Prefilled Autoinjector/Pen
Phase of Trial: Phase III
Latest Information Update: 07 Sep 2018
At a glance
- Drugs Evolocumab (Primary)
- Indications Dyslipidaemias; Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms PROFICIO; THOMAS-1
- Sponsors Amgen
- 01 Mar 2017 Results (n=6026) of pooled safety analysis of this and other eleven trials (LAPLACE-TIMI 57,RUTHERFORD,GAUSS,MENDEL,YUKAWA,LAPLACE-2,RUTHERFORD-2,GAUSS-2,MENDEL-2,DISCARTES,THOMAS-1,THOMAS-2) published in the Circulation.
- 28 Aug 2014 Amgen submitted a BLA to the US FDA for evolocumab based on data from this trial and 9 other trials in the PROFICIO programme, according to a media release.
- 26 Nov 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.