NCT00650819

Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)

A Multicenter, Double-blind, Randomized, Active-controlled Parallel Groups Study Comparing The Efficacy and Safety of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg Vs Simvastatin Or Ezetimibe Alone in Subjects With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (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; active-controlled parallel groups study enrolling subjects with primary hypercholesterolemia. Subjects receive ezetimibe, simvastatin, or the combination once daily for 8 weeks to determine the effect on LDL-cholesterol.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Ezetimibe + Simvastatin	ezetimibe 10 mg plus simvastatin 20 mg once daily for 8 weeks
DRUG	Simvastatin	simvastatin 20 mg plus ezetimibe placebo once daily for 8 weeks
DRUG	Ezetimibe	Ezetimibe 10 mg plus simvastatin placebo once daily for 8 weeks

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2008-04-02
• Last updated: 2024-08-15