Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
NCT ID: NCT00418834
Last Updated: 2024-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1053 participants
INTERVENTIONAL
2007-01-31
2008-10-31
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
ezetimibe and atorvastatin
ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
Placebo (unspecified)
Placebo (unspecified) daily for 12 weeks
2
atorvastatin
Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
Placebo (unspecified)
Placebo (unspecified) daily for 12 weeks
Interventions
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ezetimibe and atorvastatin
ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
atorvastatin
Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
Placebo (unspecified)
Placebo (unspecified) daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Patient is willing to maintain cholesterol lowering diet
* Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category
Exclusion Criteria
* Patient is unlikely to be compliant in taking study medication
* Patient with chronic or unstable medical condition
* Patient is taking unstable doses of medication
* Patient drinks more than 2 alcoholic drinks per day
* Patient has elevations in certain laboratory values (CK, AST, ALT)
65 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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Zieve F, Wenger NK, Ben-Yehuda O, Constance C, Bird S, Lee R, Hanson ME, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe added to atorvastatin versus up titration of atorvastatin to 40 mg in Patients > or = 65 years of age (from the ZETia in the ELDerly [ZETELD] study). Am J Cardiol. 2010 Mar 1;105(5):656-63. doi: 10.1016/j.amjcard.2009.10.029. Epub 2009 Dec 24.
Constance C, Ben-Yehuda O, Wenger NK, Zieve F, Lin J, Hanson ME, Lowe RS, Tershakovec AM. Atorvastatin 10 mg plus ezetimibe versus titration to atorvastatin 40 mg: attainment of European and Canadian guideline lipid targets in high-risk subjects >/=65 years. Lipids Health Dis. 2014 Jan 13;13:13. doi: 10.1186/1476-511X-13-13.
Other Identifiers
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MK0653-112
Identifier Type: -
Identifier Source: secondary_id
2006_549
Identifier Type: -
Identifier Source: secondary_id
0653-112
Identifier Type: -
Identifier Source: org_study_id
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