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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00652431 | Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2) | PHASE1 | COMPLETED | 18 | — | — | May 1, 2007 | Jul 1, 2007 | Feb 16, 2022 | - | — |
| Arm | Type | Description |
|---|---|---|
| Vytorin + Niaspan | EXPERIMENTAL | NIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 + VYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days |
| Vytorin | ACTIVE_COMPARATOR | VYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days |
| Niaspan | ACTIVE_COMPARATOR | NIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 for a total of 7 days of treatment |
| Name | Type | Description |
|---|---|---|
| Vytorin + Niaspan | DRUG | Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days + Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7 |
| Vytorin | DRUG | Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days |
| Niaspan | DRUG | Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7 |
Inclusion Criteria: The subject must meet ALL the criteria listed below for entry: * Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules. * Subjects of either sex and of any race between the ages of 18 and 55 years, inclusive, having a Body Mass...