NCT00651274

Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)

A Multicenter, Randomized, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, And Tolerability Of The Daily Co-administration Of Ezetimibe 10 Mg Or Ezetimibe Placebo To Ongoing Treatment With Simvastatin 20 Mg In Subjects With Primary Hypercholesterolemia And Coronary Heart Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.

Conditions

• Atherosclerosis
• Hypercholesterolemia
• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Ezetimibe	oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
DRUG	Placebo	oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2008-04-02
• Last updated: 2024-08-15