Odyssey Options II
Research type
Research Study
Full title
A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin
IRAS ID
119866
Contact name
Adie Viljoen
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2012-002333-11
ISRCTN Number
n/a
Research summary
This is a study of the investigational drug, REGN727 (“study drugâ€). REGN727 is also known as SAR236553. This is a randomised, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with hypercholesterolaemia who are not effectively controlled with rosuvastatin (10 mg or 20 mg) with or without other lipid-modifying therapy (excluding ezetimibe).Patients who take part in the study are taking either rosuvastatin 10 mg or rosuvastatin 20 mg. Patients taking rosuvastatin 10 mg are randomised to 1 of 3 treatment arms (arms 1 to 3); and patients taking rosuvastatin 20 mg are randomised to 1 of 3 treatment arms (arms 4 to 6). The treatment arms are as follows: Patients on a 10 mg rosuvastatin regimen:1. REGN727 rosuvastatin 10 mg placebo-ezetimibe2. Placebo-REGN727 rosuvastatin 20 mg placebo-ezetimibe3. Placebo-REGN727 rosuvastatin 10 mg EZE 10 mg. Patients on a 20 mg atorvastatin regimen:4. REGN727 rosuvastatin 20 mg placebo-ezetimibe5. Placebo-REGN727 rosuvastatin 40 mg placebo-ezetimibe6. Placebo-REGN727 rosuvastatin 20 mg ezetimibe 10 mg. This study will include about 300 participants at about 60 research centres in North America, South America, Europe and Australia. The study may last up to 11 months and includes 9 scheduled study visits. The study consists of 3 periods: screening (up to 6 weeks), double-blind treatment (24 weeks) and follow up (8 weeks).
REC name
East of England - Essex Research Ethics Committee
REC reference
12/EE/0533
Date of REC Opinion
14 Mar 2013
REC opinion
Further Information Favourable Opinion