To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
NCT ID: NCT00271817
Last Updated: 2024-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1220 participants
INTERVENTIONAL
2005-12-31
2008-02-29
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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Part 1 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Comparator: ezetimibe/simvastatin + niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks
Part 1 -Arm 2
ezetimibe/simvastatin
Comparator: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~24 weeks.
Comparator: Placebo to Niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be \~24 weeks.
Part 1 - Arm 3
Niacin (ER)
Comparator: Placebo to ezetimibe/simvastatin
ezetimibe/simvastatin (Pbo) tablet. Treatment time will be \~24 weeks.
Comparator: niacin (ER) tablet
niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks
Part 2 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Comparator: ezetimibe/simvastatin and niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be \~40 additional weeks for a total of 64 weeks
Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
Comparator: ezetimibe and simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks
Comparator: Placebo to niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks
Interventions
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Comparator: ezetimibe/simvastatin + niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks
Comparator: Placebo to ezetimibe/simvastatin
ezetimibe/simvastatin (Pbo) tablet. Treatment time will be \~24 weeks.
Comparator: niacin (ER) tablet
niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be \~24 weeks
Comparator: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~24 weeks.
Comparator: Placebo to Niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be \~24 weeks.
Comparator: ezetimibe/simvastatin and niacin (ER)
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be \~40 additional weeks for a total of 64 weeks
Comparator: ezetimibe and simvastatin
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks
Comparator: Placebo to niacin (ER)
Niacin (ER) (Pbo) tablet. Treatment time will be \~40 additional weeks for a total of 64 weeks
Eligibility Criteria
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Inclusion Criteria
* Patient willing to be on a low-cholesterol diet
Exclusion Criteria
* Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
* Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
* Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
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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Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72. doi: 10.1016/j.jacc.2008.03.003.
Le NA, Jin R, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. J Am Heart Assoc. 2013 Aug 7;2(4):e000037. doi: 10.1161/JAHA.113.000037.
Guyton JR, Fazio S, Adewale AJ, Jensen E, Tomassini JE, Shah A, Tershakovec AM. Effect of extended-release niacin on new-onset diabetes among hyperlipidemic patients treated with ezetimibe/simvastatin in a randomized controlled trial. Diabetes Care. 2012 Apr;35(4):857-60. doi: 10.2337/dc11-1369. Epub 2012 Feb 14.
Other Identifiers
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2005_091
Identifier Type: -
Identifier Source: secondary_id
0653A-091
Identifier Type: -
Identifier Source: org_study_id
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