20140128 GLAGOV Extension study
Research type
Research Study
Full title
An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
IRAS ID
179140
Contact name
Azfar Zaman
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2014-001524-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 22 days
Research summary
Cardiovascular disease is a leading cause of death in developed countries. It's commonly linked with having high cholesterol levels in the blood. This cholesterol can be deposited in the walls of the blood vessels making them narrow which can reduce the blood flow to critical areas of the body, such as the heart. By lowering cholesterol levels in the blood, the amount deposited in the walls of the blood vessels should also decrease. A common method to lower cholesterol is using medications such as statins.
Evolocumab (AMG145) is an experimental drug that works differently to statins and other cholesterol lowering medications, and has been shown to further lower LDL cholesterol, the type of cholesterol associated with narrowing blood vessels. The purpose of this study is to determine the long term safety, tolerability and efficacy of evolocumab.
Patients will be eligible for the study if they completed the Amgen 20120153 study and remained on IP (evolocumab) at the end of the study. Patients will be required to give their written informed consent before any study related procedures commence.
Patients will be on the study for up to 2 years, having study product administered every 4 weeks. Patients will visit the study site on day 1, week 4, quarterly for the first year and twice in year two. Evolocumab can either be self-administered at home or given at the study site. Patients will also receive optimised lipid-lowering therapy during the study and will continue taking Amgen provided Atorvastatin for the first 12 weeks of this study if they were doing so on the qualifying study (Amgen 20120153). Patients will have following assessments during the study: heart rate, blood pressure, body weight and waist circumference measurements, blood collections (including pregnancy testing) and physical examination. Medication use and adverse events will also be discussed during each visit.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0210
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion