NCT00413972

Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)

A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Groups Study Comparing the Efficacy and Safety of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ezetimibe with simvastatin	Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks
DRUG	Ezetimibe with Simvastatin	Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks
DRUG	Ezetimibe with Simvastatin	Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks
DRUG	Placebo	Placebo once daily for a total of eight weeks

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-12-20
• Last updated: 2022-02-09
• Results posted: 2010-05-25