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:	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 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 ]
Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%

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 in HDL-C = [(week 6 value - baseline value)/baseline value]*100%
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 in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%
Percent Change From Baseline to Week 6 in Total-Cholesterol [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%
Percent Change From Baseline to Week 6 in Triglycerides (TG) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%
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 in Apo B = [(week 6 value - baseline value)/baseline value]*100%
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 in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%
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 in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
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 in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
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 in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
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 in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) [ Time Frame: Baseline and 6 Weeks ] [ Designated as safety issue: No ]
Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%
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
Active Comparator: 1 Atorvastatin 80 mg	Drug: atorvastatin Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
Experimental: 2 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

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bays H, Conard S, Leiter LA, Bird S, Jensen E, Hanson ME, Shah A, Tershakovec AM. Are post-treatment low-density lipoprotein subclass pattern analyses potentially misleading? Lipids Health Dis. 2010 Nov 30;9:136.

Conard S, Bays H, Leiter LA, Bird S, Lin J, Hanson ME, Shah A, Tershakovec AM. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab. 2010 Mar;12(3):210-8.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00276484 History of Changes
Other Study ID Numbers:	2005_105, MK0653-090
Study First Received:	January 11, 2006
Results First Received:	February 6, 2009
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 09, 2012