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

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 High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276484
• Other study ID #: 0653-090
• Secondary ID: 2005_105
• Status: Completed
• Phase: Phase 3
• Start date: February 2006
• Est. completion date: March 2008

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• atorvastatin
Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
• atorvastatin
Atorvastatin 40 mg by mouth, once a day for 6 weeks
• ezetimibe
Ezetimibe 10 mg tablets 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)

Leiter LA, Bays H, Conard S, Bird S, Rubino J, Hanson ME, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1495-501. doi: 10.1016/j.amjcard.2008.09.076. Epub 2008 Oct 23. — View Citation

Outcome

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