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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276458
• Other study ID #: 0653-079
• Secondary ID: 2005_104
• Status: Completed
• Phase: Phase 3
• Start date: February 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Comparator: atorvastatin
Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
• Comparator: Placebo
Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
• Comparator: ezetimibe
Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
• Comparator: Placebo.
Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

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