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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: atorvastatin; Drug: ezetimibe

• Registration Number: NCT00276484
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Study Start: 2006-02
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Results First Submitted: 2009-02-06
• Results First Submitted QC: 2009-03-10
• Results First Posted: 2009-04-13
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 579

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ezetimibe	Atorvastatin 40 mg + ezetimibe 10 mg
1	atorvastatin	Atorvastatin 80 mg
2	atorvastatin	Atorvastatin 40 mg + ezetimibe 10 mg

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C	Baseline and 6 weeks	Percent Change in LDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 6 in Triglycerides (TG)	Baseline and 6 Weeks	Percent Change in TG = \[(week 6 value - baseline value)/baseline value\]\*100%
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6	6 Weeks
Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)	Baseline and 6 weeks	Percent Change in HDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)	Baseline and 6 Weeks	Percent Change in Non-HDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Percent Change From Baseline to Week 6 in Total-Cholesterol	Baseline and 6 Weeks	Percent Change in Total-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)	Baseline and 6 Weeks	Percent Change in Apo B = \[(week 6 value - baseline value)/baseline value\]\*100%
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio	Baseline and 6 Weeks	Percent Change in LDL-C:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)	Baseline and 6 Weeks	Percent Change in Apo A-I = \[(week 6 value - baseline value)/baseline value\]\*100%
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio	Baseline and 6 Weeks	Percent Change in Apo B:Apo A-I Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio	Baseline and 6 Weeks	Percent Change in TC:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio	Baseline and 6 Weeks	Percent Change in non-HDL-C:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)	Baseline and 6 Weeks	Percent Change in CRP = \[(week 6 value - baseline value)/baseline value\]\*100%