drugset / Trial / NCT00413972
Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)
Phase 3
Completed
392 enrolled
Organon and Co
Merck Sharp & Dohme LLC · collabSchering-Plough · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 consecutive weeks in subjects with primary hypercholesterolemia (LDL-C \>3.64 mmol/L \[140 mg/dL\]). The efficacy of daily Vytorin versus placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily Vytorin versus placebo with respect to change in the concentrations of total cholesterol, triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be assessed.
Timeline
- Start
- 2006-04
- Primary completion
- 2006-11
- Completion
- 2006-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Subject | Simvastatin | Small molecule | 10 mg | — |
| Subject | Simvastatin | Small molecule | 20 mg | — |
| Subject | Simvastatin | Small molecule | 40 mg | — |