NCT00653835

Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)

SCH 58235: A Multicenter, Randomised, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, and Tolerability Of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg vs Ezetimibe Placebo With Simvastatin 20 mg in Untreated Subjects With Primary Hypercholesterolaemia And Coronary Heart Disease (Protocol P03435)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.

Conditions

• Hypercholesterolaemia
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Ezetimibe + Simvastatin	oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
DRUG	Simvastatin	oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks

Timeline

• Start date: 2003-09-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2008-04-07
• Last updated: 2024-08-15