A Phase 3 study: AMG145 in Heterozygous Familial Hypercholesterolemia

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia

• IRAS ID

  108070

• Contact name

  Handrean Soran

• Eudract number

  2012-001365-32

• Research summary

  Cardiovascular disease is a leading cause of death in developed countries. Cardiovascular disease is commonly linked with having high cholesterol levels in the blood stream. By lowering cholesterol levels, the risk of problems that occur in cardiovascular disease such as heart attacks and strokes is also reduced. A common method to lower cholesterol levels is medication such as statins. AMG 145 is a new experimental drug that works in a different way to statins and the purpose of this study is to find out more about AMG 145 in people with heterozygous familial hypercholesterolemia. This study will examine if treatment with AMG 145 will result in lower levels of low-density lipoprotein cholesterol (LDL-cholesterol; ??bad? cholesterol as compared to placebo and whether AMG 145 causes any side effects. Patients will be randomly allocated to one of the four treatment groups: 1) 2mls of AMG145 injection every 2 weeks 2) 6mls of AMG145 injection every 4 weeks 3) 2mls of placebo injection every 2 weeks 4) 6mls of placebo injection every 4 weeks Neither the doctor or the patient will know if they are receiving AMG 145 or placebo. Patients will be allowed to remain on a stable dose of statin or other approved lipid lowering drugs. The patients will be screened for up to 6 weeks (including the placebo run in period to confirm tolerance to the injections) 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 - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0682

• Date of REC Opinion

  6 Nov 2012

• REC opinion

  Further Information Favourable Opinion