To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
NCT ID: NCT00276458
Last Updated: 2024-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
196 participants
INTERVENTIONAL
2006-02-28
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
Comparator: atorvastatin
Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
Comparator: Placebo
Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
2
Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
Comparator: ezetimibe
Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
Comparator: Placebo.
Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.
Interventions
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Comparator: atorvastatin
Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
Comparator: Placebo
Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
Comparator: ezetimibe
Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
Comparator: Placebo.
Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient with sensitivity or intolerance to ezetimibe or atorvastatin
* Patient with diabetes or coronary heart disease
18 Years
79 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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. doi: 10.1016/j.amjcard.2008.09.075. Epub 2008 Oct 23.
Other Identifiers
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2005_104
Identifier Type: -
Identifier Source: secondary_id
0653-079
Identifier Type: -
Identifier Source: org_study_id
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