To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

Phase 3

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00276458
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Study Start: 2006-02
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2008-12-18
• Results First Submitted QC: 2009-05-14
• Results First Posted: 2009-07-08
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg

Exclusion Criteria

• Pregnant or lactating women or intending to become pregnant
• Patient with sensitivity or intolerance to ezetimibe or atorvastatin
• Patient with diabetes or coronary heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6	6 weeks	\[(6 week value - baseline value)/baseline value\]\*100%.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6	6 Weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6	6 Weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6	6 weeks
Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6	6 weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6	6 Weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change From Baseline in Total-Cholesterol at Week 6	6 Weeks	(\[6 week value - baseline value)/baseline value\]\*100%.
Percent Change From Baseline in Apolipoprotein B at Week 6	6 Weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6	6 Weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change From Baseline in Triglycerides (TG) at Week 6	6 weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6	6 Weeks	\[(6 week value - baseline value)/baseline value\]\*100%.
Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6	6 Weeks	\[(6 week value - baseline value)/baseline value\]\*100%.