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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00276458

First received: January 10, 2006

Last updated: April 10, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 10, 2006

Last Updated Date

April 10, 2013

Start Date ^ICMJE

February 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

[(6 week value - baseline value)/baseline value]*100%.

Original Primary Outcome Measures ^ICMJE

Change in LDL-C

Change History

Complete list of historical versions of study NCT00276458 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in Total-Cholesterol at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
([6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in Triglycerides (TG) at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in Apolipoprotein B at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
[(6 week value - baseline value)/baseline value]*100%.
Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in other lipid variables

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Drug: Comparator: atorvastatin
Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
Drug: Comparator: Placebo
Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
Drug: Comparator: ezetimibe
Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
Drug: Comparator: Placebo.
Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Study Arm (s)

Active Comparator: 1
Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
Interventions:
- Drug: Comparator: atorvastatin
- Drug: Comparator: Placebo
Experimental: 2
Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
Interventions:
- Drug: Comparator: ezetimibe
- Drug: Comparator: Placebo.

Publications *

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. Epub 2008 Oct 23.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

196

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00276458

Other Study ID Numbers ^ICMJE

2005_104, MK0653-079

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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