Clinical trial NCT00276458: To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-01-13
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
timeFrame: 6 weeks
Secondary outcomes:
measure: Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
timeFrame: 6 weeks
measure: Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
timeFrame: 6 Weeks
measure: Percent Change From Baseline in Total-Cholesterol at Week 6
timeFrame: 6 Weeks
measure: Percent Change From Baseline in Triglycerides (TG) at Week 6
timeFrame: 6 weeks
measure: Percent Change From Baseline in Apolipoprotein B at Week 6
timeFrame: 6 Weeks
measure: Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
timeFrame: 6 Weeks
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
timeFrame: 6 Weeks
measure: Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
timeFrame: 6 Weeks
measure: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
timeFrame: 6 Weeks
measure: Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
timeFrame: 6 Weeks
measure: Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.