Clinical Trials Directory

Trials / Completed

CompletedNCT00166504

Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia

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

Summary

This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Conditions

Interventions

TypeNameDescription
DRUGezetimibe (+) simvastatinsimvastatin/ezetimibe 10/20 mg
DRUGatorvastatinatorvastatin 10 mg

Timeline

Start date
2005-10-01
Primary completion
2007-10-01
Completion
2007-10-01
First posted
2005-09-14
Last updated
2024-05-22
Results posted
2008-11-05

Source: ClinicalTrials.gov record NCT00166504. Inclusion in this directory is not an endorsement.