A Phase 3 Study with AMG 145/Ezetimibe in Hypercholesterolemia

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

• IRAS ID

  108071

• Contact name

  Nigel Capps

• Sponsor organisation

  Amgen Limited

• Eudract number

  2012-001364-30

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Cardiovascular disease is a leading cause of death in developed countries and is commonly linked with high cholesterol levels in the blood stream. By lowering cholesterol levels, the risk of problems that occur in cardiovascular disease (e.g. heart attacks and strokes) is also reduced. A common method to lower cholesterol levels is medication such as statins. This study is designed to see whether an investigational product called AMG 145 given to participants with dyslipidemia (abnormal amounts of lipids (e.g. fats) in the blood) who cannot tolerate an effective dose of a statin, causes any side effects and to evaluate whether treatment with AMG 145 will lower low-density lipoprotein cholesterol (LDL-cholesterol; ??bad? cholesterol )in these people. AMG 145 will be compared with ezetimibe. Patients will be randomly allocated to one of four treatment groups: 1) 2mls of AMG145 injection every 2 weeks and placebo (a product that has no active ingredients)taken daily by mouth 2) 6mls of AMG145 injection every 4 weeks and placebo taken daily by mouth 3) 2mls of placebo injection every 2 weeks and ezetimibe taken daily by mouth 4) 6mls of placebo injection every 4 weeks and ezetimibe taken daily by mouth Neither the doctor or the patient will know if they are receiving AMG 145 and placebo or placebo and ezetimibe. Screening will last for up to 6 weeks (including the placebo run in period to confirm tolerance to the injections) to see if patients are eligible before being put into a study group. The study duration is approximately 14 weeks and involves consenting to the study, receiving AMG 145 or placebo and other required medication, medical examinations, blood pressure and heart rate measurements, heart electrical activity (ECG) measurements, collecting laboratory samples, height, weight and waist measurements and collecting/reviewing information about their health throughout the study.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0290

• Date of REC Opinion

  18 Oct 2012

• REC opinion

  Further Information Favourable Opinion