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:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Secondary Outcome Measures:

Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Total-Cholesterol at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Triglycerides (TG) at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline in Apolipoprotein B at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
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 ]
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 ]
Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
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 ]
Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
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
1: Active Comparator 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
2: Experimental 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

PhRMA Clinical Study Results Database - web-based repository for clinical study results 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_104, MK0653-079
Study First Received:	January 10, 2006
Results First Received:	December 18, 2008
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00276458 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 05, 2009