A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
Phase 3
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00535405
- Lead Sponsor
- Organon and Co
- Brief Summary
A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1289
Inclusion Criteria
- Patient has a cholesterol level of 130 mg/dL or greater
- Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
- Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines
Exclusion Criteria
- Patient weighs less than 100 lbs
- Patient has an allergy to ezetimibe, simvastatin or atorvastatin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Atorvastatin 20 mg Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. 1 Atorvastatin 10 mg Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. 2 Ezetimibe 10 mg/simvastatin 20 mg Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. 4 Ezetimibe 10 mg/simvastatin 40 mg Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. 5 Atorvastatin 40 mg Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 Baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 12 weeks Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 12 Weeks Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 12 Weeks Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 12 Weeks Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 12 Weeks