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

Official Title: “A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease”

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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin 10 mg
  • Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
• Drug: Ezetimibe 10 mg/simvastatin 20 mg
  • Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
• Drug: Atorvastatin 20 mg
  • Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
• Drug: Ezetimibe 10 mg/simvastatin 40 mg
  • Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
• Drug: Atorvastatin 40 mg
  • Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 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.
• Experimental: 2
  • 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.
• Experimental: 3
  • 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.
• Experimental: 4
  • 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.
• Experimental: 5
  • 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 Measures

• Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No

Secondary Measures

• Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No
• 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
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
  • Time Frame: 12 Weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535405

Study ID Number: 2007_588

ClinicalTrials.gov Identifier: NCT00535405

Health Authority: United States: Food and Drug Administration