Phase 3 N=579 Randomized Double-blind Treatment

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT00276484 ↗

Enrolled (actual)

579

Serious AEs

—

Results posted

Apr 2009

Primary outcome: Primary: Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C — -27.4; -11.0 Percent Change — p=<0.001

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C	-27.4; -11.0	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)	-0.5; -1.0	0.551
SECONDARY Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)	-23.3; -9.0	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in Total-Cholesterol	-16.9; -6.9	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in Triglycerides (TG)	-12.3; -5.9	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)	-17.8; -7.7	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)	-0.3; -1.2	0.313
SECONDARY Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio	-16.0; -5.6	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio	-26.4; -9.9	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio	-16.9; -5.9	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio	-22.2; -7.6	<0.001 sig
SECONDARY Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)	-18.3; -11.5	0.174
SECONDARY Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6	204; 88; 73; 191	<0.001 sig

Summary

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.

Eligibility Criteria

Inclusion Criteria

Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg

Exclusion Criteria

Pregnant or lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe or atorvastatin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00276484). 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.