Approval Probability
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Also known as Atorvastatin injection
Atorvastatin · 1 trial · 2 indications
LDL-C levels were measured prior to and at the end of the 15 day treatment period to quantify the percent baseline LDL-C at 15 days. Efficacy is defined as eleven or more subjects in a dosing cohort with a Day 15 LDL-C not more than 125% of their baseline.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 2 | EXPERIMENTAL | Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 3 | EXPERIMENTAL | Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 4 | EXPERIMENTAL | Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days |
| Name | Type | Description |
|---|---|---|
| Atorvastatin injection | DRUG | statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection |
Inclusion Criteria: * On stable dose of daily oral atorvastatin for \>= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin) * Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase. Exclusion ...