Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen

Summary

The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.

Timeline

Start

2013-04-18

Primary completion

2013-09-02

Completion

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Publications

• Background Boccara F, Dent R, Ruilope L, Valensi P. Practical Considerations for the Use of Subcutaneous Treatment in the Management of Dyslipidaemia. Adv Ther. 2017 Aug;34(8):1876-1896. doi: 10.1007/s12325-017-0586-8. Epub 2017 Jul 17.
• Background Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.
• Background Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
• Dent R, Joshi R, Stephen Djedjos C, Legg J, Elliott M, Geller M, Meyer D, Somaratne R, Recknor C, Weiss R. Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting. Springerplus. 2016 Mar 9;5:300. doi: 10.1186/s40064-016-1892-3. eCollection 2016.

Drugs

Indications