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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01592240 | Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin | PHASE2 | COMPLETED | 354 | — | — | Jul 1, 2012 | May 1, 2013 | Dec 5, 2017 | 74 | United States |
| Arm | Type | Description |
|---|---|---|
| Q28d Dosing Arm | EXPERIMENTAL | A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month. |
| Q14d Dosing Arm | EXPERIMENTAL | A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| PBO | DRUG | Placebo Q28d |
| 200mg PF-04950615 (RN316) | DRUG | PF-04950615 200 mg, Q28d |
| 300mg PF-04950615 (RN316) | DRUG | PF-04950615 300 mg, Q28d |
| PF-04950615 | DRUG | PF-04950615 50mg, Q14d |
Inclusion Criteria: * Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial. * Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and...