Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vytorin+ Niaspan · 1 trial · 2 indications
| 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...
Vytorin+ Niaspan is an investigational combination being studied for hypercholesterolemia, a condition of high cholesterol. It is a small molecule therapy in the cardiovascular therapeutic area. The drug is currently in Phase 1 clinical development and is not yet approved for any use.
Vytorin+ Niaspan is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate this combination therapy for hypercholesterolemia.
Vytorin+ Niaspan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for hypercholesterolemia.
Vytorin+ Niaspan has one completed Phase 1 clinical trial, identified as NCT00652431. This study, titled 'Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2),' enrolled 18 participants and was an active-controlled, randomized trial. The trial is completed.
Vytorin+ Niaspan is a combination of Vytorin and Niaspan, two existing cholesterol medications. The combination is being studied as a single therapy for hypercholesterolemia. It is distinct from either drug alone and is currently in Phase 1 clinical trials.