Clinical trial NCT00479713: A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
Official title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: High Cholesterol
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 618
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: This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.


Eligibility criteria: Inclusion Criteria:

* Participant is currently taking a statin medication for the treatment of high cholesterol
* Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl

Exclusion Criteria:

* Women who are pregnant or nursing, or women who intend to become pregnant
* Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study

Primary outcomes:
measure: Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment
timeFrame: after 6 weeks of treatment
Other outcomes:
measure: Percent Change From Baseline in Total Cholesterol
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in Triglycerides.
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in Apolipoprotein B
timeFrame: Baseline and 6 weeks
measure: Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein
timeFrame: Baseline and 6 weeks
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Farnier M, Averna M, Missault L, Vaverkova H, Viigimaa M, Massaad R, Vandormael K, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009 Apr;63(4):547-59. doi: 10.1111/j.1742-1241.2009.02022.x. Epub 2009 Feb 16.
citation: Averna M, Missault L, Vaverkova H, Farnier M, Viigimaa M, Dong Q, Shah A, Johnson-Levonas AO, Taggart W, Brudi P. Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome. Diab Vasc Dis Res. 2011 Oct;8(4):262-70. doi: 10.1177/1479164111418136. Epub 2011 Aug 22.
citation: Viigimaa M, Vaverkova H, Farnier M, Averna M, Missault L, Hanson ME, Dong Q, Shah A, Brudi P. Ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk hypercholesterolemic patients stratified by prior statin treatment potency. Lipids Health Dis. 2010 Nov 4;9:127. doi: 10.1186/1476-511X-9-127.