At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Double Blind, Parallel Group, Placebo Controlled, Randomized, Dose Ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Twice Monthly Subcutaneous Doses In Hypercholesterolemic Japanese Subjects Who Are Receiving A Stable Dose Of Atorvastatin Or Treatment Naïve.
In Brief
A Phase 2 clinical trial evaluating Bococizumab (PF-04950615;RN316), Placebo, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 218 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.
Study Details
Timeline
Interventions
Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week
Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week
Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week
Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week
Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
50 mg Q14D SC for 16 week
100 mg Q14D SC for 16 week
150 mg Q14D SC for 16 week
Placebo Q14D SC for 16 week