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)
- Registration Number
- NCT00479713
- Lead Sponsor
- Organon and Co
- Brief Summary
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 618
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ezetimibe (+) simvastatin Arm 1: drug
- Primary Outcome Measures
Name Time Method Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment Baseline and 6 weeks Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
- Secondary Outcome Measures
Name Time Method The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment after 6 weeks of treatment The percentage of participants who achieved a target LDL-C goal of \< 100 mg/dL, of \<70 mg/dL, and of \<77 mg/dL at study endpoint after six weeks of treatment.
The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group.