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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01720537 | A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects | PHASE1 | COMPLETED | 133 | — | — | Jul 1, 2012 | Oct 1, 2013 | Dec 4, 2018 | 7 | United States |
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Cohort 6 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-05335810 Dose A | BIOLOGICAL | Single SC Injection |
| PF-05335810 Dose B | BIOLOGICAL | Single Subcutaneous Injection(s) |
| Placebo | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-04950615 Dose A | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose C | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-04950615 | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose D | BIOLOGICAL | Single Subcutaneous Injection(s) |
| PF-05335810 Dose E | BIOLOGICAL | Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months. |
Inclusion Criteria: * On stable daily doses of a statin for 45 days prior to receiving study treatment. * Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization. Exclusion Criteria: * History of a cardiovascular or cerebrovascular event or ...