Clinical trial NCT00271817: To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Official title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-01-04
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.


Eligibility criteria: Inclusion Criteria:

* Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
* Patient willing to be on a low-cholesterol diet

Exclusion Criteria:

* Pregnant or lactating women or intending to become pregnant
* 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

Primary outcomes:
measure: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline and 24 Weeks
measure: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
timeFrame: Baseline and 24 weeks
measure: Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline and 24 weeks
measure: Percent Change From Baseline in Triglycerides (TG)
timeFrame: baseline and 24 Weeks
measure: Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline and 64 weeks
measure: Percent Change From Baseline in Triglycerides (TG)
timeFrame: Baseline and 64 weeks
measure: Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
timeFrame: Baseline and 64 weeks
measure: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline and 64 weeks
measure: Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.