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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01342211 | A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins | PHASE2 | COMPLETED | 93 | — | — | Jul 1, 2011 | Jun 1, 2012 | Oct 11, 2017 | 44 | United States, Canada |
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
| Arm | Type | Description |
|---|---|---|
| Treatment A | PLACEBO_COMPARATOR | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | EXPERIMENTAL | - |
| Treatment D | EXPERIMENTAL | - |
| Treatment E | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Intravenous placebo monthly during treatment phase. |
| Statin | DRUG | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
| PF-04950615 (RN316) | BIOLOGICAL | Intravenous 10mg/mL based on weight monthly during treatment phase. |
| Satin | DRUG | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
Inclusion Criteria: * On a stable daily dose of atorvastatin, rosuvastatin or simvastatin. * Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL Exclusion Criteria: * History of a cardiovascular or cerebrovas...