Study in patients with high cholesterol and at risk of heart disease

• Research type

  Research Study

• Full title

  Long-term safety and tolerability of SAR236553 (REGN727) in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their lipid modifying therapy: a randomized, double-blind, placebo-controlled study

• IRAS ID

  98817

• Contact name

  Peter Harvey

• Sponsor organisation

  sanofi-aventis Recherche & Développement

• Eudract number

  2011-002806-59

• ISRCTN Number

  not known

• Research summary

  High blood cholesterol, particularly an increase in low-density lipoprotein cholesterol (LDL-C) levels, constitutes a major risk for the development of atherosclerosis and coronary heart disease (CHD), the leading cause of death and disability in the Western world. Many studies have demonstrated a strong direct relationship between LDL-C level and CHD events, and recent data suggests that the lower the LDL-C level, the greater the benefit. The purpose of the study is to determine if the study drug(SAR236553), given by injection under the skin, for 18 months is effective and safe compared to placebo in reducing blood cholesterol levels, particularly when added to the cholesterol lowering drugs already used by participants. The study will enrol 2100 patients worldwide. Participation may last up to 20 months and include a maximum of 13 scheduled visits. During these scheduled visits patients will undergo a number of procedures to confirm safety and the effectiveness of the study drug (including vital signs, physical examination, ECG and blood/urine sample collection for laboratory tests). The study will be conducted at 11 sites in the UK, including GP surgeries, hospitals and dedicated research centres.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  12/LO/0262

• Date of REC Opinion

  23 Mar 2012

• REC opinion

  Further Information Favourable Opinion