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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00653913 | Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED) | PHASE1 | COMPLETED | 18 | — | — | Mar 1, 2004 | Sep 1, 2004 | Feb 16, 2022 | - | — |
| Arm | Type | Description |
|---|---|---|
| Group A | ACTIVE_COMPARATOR | SCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3) |
| Group B | ACTIVE_COMPARATOR | SCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3) |
| Group C | ACTIVE_COMPARATOR | Pitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3) |
| Group D | ACTIVE_COMPARATOR | Pitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3) |
| Group E | ACTIVE_COMPARATOR | Coadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3) |
| Group F | ACTIVE_COMPARATOR | Coadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3) |
| Name | Type | Description |
|---|---|---|
| SCH 58235 | DRUG | SCH 58235 10 mg (once daily) |
| pitavastatin | DRUG | Pitavastatin 2 mg (once daily) |
Inclusion Criteria: * Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels. * Aged 20 years or over and 65 years or below when the informed consent is obtained. * Weighing 50 kg or over and 80 kg or below on t...