Odyssey Options I

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atovastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase versus Switch to Rosuvastatin in Patients Who are Not Controlled on Atorvastatin

• IRAS ID

  117586

• Contact name

  Adie Viljoen

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2012-002344-24

• ISRCTN Number

  No number

• Clinicaltrials.gov Identifier

  No number

• Research summary

  This is a study of the investigational drug, REGN727 (“study drug”). REGN727 is also known as SAR236553. This is a randomised, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with non-familial hypercholesterolaemia who are not effectively controlled with atorvastatin (20 mg or 40 mg) with or without other lipid-modifying therapy (excluding ezetimibe).Patients who take part in the study are taking either atorvastatin 20 mg or atorvastatin 40 mg. Patients taking atorvastatin 20 mg are randomised to 1 of 3 treatment arms (arms 1 to 3); and patients taking atorvastatin 40 mg are randomised to 1 of 4 treatment arms (arms 4 to 7). The treatment arms are as follows: Patients on a 20 mg atorvastatin regimen:1. REGN727 atorvastatin 20 mg placebo-ezetimibe2. Placebo-REGN727 atorvastatin 40 mg placebo-ezetimibe3. Placebo-REGN727 atorvastatin 20 mg EZE 10 mg Patients on a 40 mg atorvastatin regimen:4. REGN727 atorvastatin 40 mg placebo-ezetimibe5. Placebo-REGN727 atorvastatin 80 mg placebo-ezetimibe6. Placebo-REGN727 rosuvastatin 40 mg placebo-ezetimibe7. Placebo-REGN727 atorvastatin 40 mg ezetimibe 10 mg. This study will include about 350 participants at about 60 research centres in North America, South America, Europe and Australia. The study may last up to 9 months and includes 9 scheduled study visits. The study consists of 3 periods: screening (up to 2 weeks), double-blind treatment (24 weeks) and follow up (8 weeks).

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  12/EE/0532

• Date of REC Opinion

  14 Mar 2013

• REC opinion

  Further Information Favourable Opinion