To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg. - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00276458

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Comparator: atorvastatin Drug: Comparator: Placebo Drug: Comparator: ezetimibe Drug: Comparator: Placebo.	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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 Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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%.

Secondary Outcome Measures:

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 ]

Enrollment:	196
Study Start Date:	February 2006
Study Completion Date:	February 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276458

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00276458 History of Changes
Other Study ID Numbers:	2005_104, MK0653-079
Study First Received:	January 10, 2006
Results First Received:	December 18, 2008
Last Updated:	April 14, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012