To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
NCT ID: NCT00276484
Last Updated: 2024-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
579 participants
INTERVENTIONAL
2006-02-28
2008-03-31
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 80 mg
atorvastatin
Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
2
Atorvastatin 40 mg + ezetimibe 10 mg
atorvastatin
Atorvastatin 40 mg by mouth, once a day for 6 weeks
ezetimibe
Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.
Interventions
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atorvastatin
Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
atorvastatin
Atorvastatin 40 mg by mouth, once a day for 6 weeks
ezetimibe
Ezetimibe 10 mg tablets 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
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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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. doi: 10.1016/j.amjcard.2008.09.076. Epub 2008 Oct 23.
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. doi: 10.1186/1476-511X-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. doi: 10.1111/j.1463-1326.2009.01152.x.
Other Identifiers
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2005_105
Identifier Type: -
Identifier Source: secondary_id
0653-090
Identifier Type: -
Identifier Source: org_study_id
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