Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02055976 | Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects | PHASE2 | COMPLETED | 218 | — | — | Mar 1, 2014 | Jan 1, 2015 | Feb 8, 2019 | 9 | Japan |
| NCT02043301 | Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm | PHASE1 | COMPLETED | 75 | — | — | Apr 1, 2014 | Nov 1, 2014 | May 31, 2019 | 6 | United States |
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = (\[observed value divided by baseline value\] minus 1) multiplied by 100.
AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Maximum observed concentration.
| Arm | Type | Description |
|---|---|---|
| Population A | EXPERIMENTAL | A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups. |
| Population B | EXPERIMENTAL | A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups. |
| Single 150 mg PF-04950615 dose administered to the abdomen | ACTIVE_COMPARATOR | - |
| Single 150 mg PF-04950615 dose administered to the upper arm | EXPERIMENTAL | - |
| Single 150 mg PF-04950615 dose administered to the thigh | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bococizumab (PF-04950615;RN316) | DRUG | Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week |
| Placebo | DRUG | Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week |
| Ezetimibe | DRUG | Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open) |
| Bococizumab (PF-04950615; RN316) | BIOLOGICAL | Single 150 mg PF-04950615 dose administered SC to the abdomen |
Inclusion Criteria: * Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A). * Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B). Exclusion Criteria: * Severe acute or chronic medical or psychiatric condi...