To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00276484

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: atorvastatin Drug: ezetimibe	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 High Risk for CHD Not Adequately Controlled on Atorvastatin 40 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 to Week 6 in Low-Density Lipoprotein (LDL)-C [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Total-Cholesterol [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Triglycerides (TG) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment:	579
Study Start Date:	February 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Atorvastatin 80 mg	Drug: atorvastatin Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
2: Experimental Atorvastatin 40 mg + ezetimibe 10 mg	Drug: atorvastatin Atorvastatin 40 mg by mouth, once a day for 6 weeks Drug: ezetimibe Ezetimibe 10 mg tablets 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 >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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276484

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:

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. Epub 2008 Oct 23.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_105, MK0653-090
Study First Received:	January 11, 2006
Results First Received:	February 6, 2009
Last Updated:	October 23, 2009
ClinicalTrials.gov Identifier:	NCT00276484 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 09, 2009