AMG145 combination study in patients with high LDL-cholesterol

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

• IRAS ID

  108068

• Contact name

  Michael Fisher

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2012-001363-70

• Research summary

  Cardiovascular disease is commonly linked with high LDL-cholesterol in the bloodstream. Lowering LDL-cholesterol may reduce cardiovascular-related problems e.g. stroke. This study is designed to see whether an investigational product called AMG145, in combination with a statin, causes any side effects and to evaluate whether treatment with AMG145 will lower LDL-cholesterol and increase HDL-cholesterol. To do this, AMG145 will be compared with placebo taken with ezetimibe in people with dyslipidemia who are prescribed statins. Patients will be randomly allocated to 2mls AMG145 or placebo every 2 weeks or 6mls AMG145 or placebo every 4 weeks at clinic. Patients will also be allocated at random to receive one of the following statins: 1) Atorvastatin 10mg plus ezetimibe or placebo 2) Atorvastatin 80mg plus ezetimibe or placebo 3) Rosuvastatin 5mg 4) Rosuvastatin 40mg or lower dose (20mg) for moderate renal impairment or Asian patients. 5) Simvastatin 40mg or lower-the dose may be adjusted depending on a patients current medication. Patients allocated to the atorvastatin (10mg or 80mg) group, patients will also be asked to take ezetimibe or a placebo by mouth once daily. This allocation is also by random assignment. Neither the doctor nor the patient will know if they are receiving AMG 145 or placebo and if it applies, ezetimibe or placebo. The patients will be screened for between 5 to 10 days to see if they are eligible for the study before being put into a study group. The study duration is approximately 14 weeks and will involve consenting to the study, receiving AMG 145 or placebo and other required medication, medical examinations, blood pressure and heart rate measurements, measuring heart electrical activity (ECG) using sticky pads placed on the skin, collecting laboratory samples, height, weight and waist measurements and collecting/reviewing information about their health throughout the study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0672

• Date of REC Opinion

  9 Nov 2012

• REC opinion

  Further Information Favourable Opinion