Phase 3 N=196 Randomized Double-blind Treatment

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

Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00276458 ↗

Enrolled (actual)

196

Serious AEs

0.0%

Results posted

Jul 2009

Primary outcome: Primary: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 — -30.8; -10.9 Percent — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: atorvastatin (Drug); Comparator: Placebo (Drug); Comparator: ezetimibe (Drug); Comparator: Placebo. (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6	-30.8; -10.9	<0.001 sig
SECONDARY Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6	3.2; 0.8	0.273
SECONDARY Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6	-26.7; -10.2	<0.001 sig
SECONDARY Percent Change From Baseline in Total-Cholesterol at Week 6	-19.7; -7.4	<0.001 sig
SECONDARY Percent Change From Baseline in Triglycerides (TG) at Week 6	-17.8; -5.5	0.159
SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 6	-21.4; -7.7	<0.001 sig
SECONDARY Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6	-20.6; -7.5	<0.001 sig
SECONDARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6	-31.9; -11.0	<0.001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6	-19.0; -5.8	<0.001 sig
SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6	-27.2; -9.9	<0.001 sig
SECONDARY Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6	-6.7; -9.2	0.841
SECONDARY Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6	77; 45; 15; 47	<0.001 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00276458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.