Date:11/9/2011

L-C levels >/= 100mg/dL.  Patients could be taking ezetimibe in addition to a daily statin.  Patients were randomized to one of four different dose regimens of REGN727/SAR236553 or placebo.  The primary endpoint of the study is the change in LDL-C from baseline over the 12-week study period.  Patients will be followed for a total of 20 weeks for safety.

A randomized, double-blind, single-dose, placebo-controlled, 90-patient trial in combination with atorvastatin in patients with primary hypercholesterolemia.  In this trial, patients on a stable dose of atorvastatin 10mg for at least 6-weeks with LDL-C levels >/= 100mg/dL or who had LDL-C levels >/= 100mg/dL after a run-in period on atorvastatin 10mg, were randomized to either (a) titration from atorvastatin 10mg to atorvastatin 80mg plus REGN727/SAR236553, (b) titration from atorvastatin 10mg to atorvastatin 80mg plus placebo, or (c) continued atorvastatin 10mg plus REGN727/SAR236553.  The primary endpoint of the study is the change in LDL-C from baseline over the 8-week study period.  Patients were followed for a total of 16 weeks for safety.

A randomized, double-blind, multi-dose, placebo-controlled, 180-patient trial in combination with atorvastatin in patients with primary hypercholesterolemia and on stable doses of atorvastatin.  In this trial, patients on a stable dose of atorvastatin 10mg, atorvastatin 20mg, or atorvastatin 40mg for at least 6-weeks with LDL-C levels >/= 100mg/dL or who had LDL-C levels >/= 100mg/dL after a run-in period on atorvastatin 10mg, atorvastatin 20mg, or atorvastatin 40mg were randomized to one of five different dose regimens of REGN727/SAR236553 plus continued atorvastatin or placebo plus continued atorvastatin. The primary endpoint of the study is the change in LDL-C from baseline over the 12-week study period.  Patients will be followed for a total of 20 weeks for safety.

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