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

A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Comparator: atorvastatin; Drug: Comparator: Placebo; Drug: Comparator: ezetimibe; Drug: Comparator: Placebo.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).	Drug: Comparator: atorvastatin; Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks; Drug: Comparator: Placebo; Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
Experimental: 2; Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).	Drug: Comparator: ezetimibe; Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.; Drug: Comparator: Placebo.; Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Conard SE, Bays HE, Leiter LA, Bird SR, Rubino J, Lowe RS, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1489-94. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: January 10, 2006
• First Submitted That Met QC Criteria: January 11, 2006
• First Posted (Estimate): January 13, 2006

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe
• Other Study ID Numbers: 0653-079; 2005_104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php