To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg.

Official Title: “A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg”

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Intervention(s) in this Clinical Trial

• Drug: Comparator: atorvastatin
  • Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks
• Drug: Comparator: Placebo
  • Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks
• Drug: Comparator: ezetimibe
  • Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.
• Drug: Comparator: Placebo.
  • Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).
• Experimental: 2
  • Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).

Primary Measures

• Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
  • Time Frame: 6 weeks
    Safety Issue?: No
• Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline in Total-Cholesterol at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline in Triglycerides (TG) at Week 6
  • Time Frame: 6 weeks
    Safety Issue?: No
• Percent Change From Baseline in Apolipoprotein B at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6
  • Time Frame: 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg

Exclusion Criteria:

• Pregnant or lactating women or intending to become pregnant
• Patient with sensitivity or intolerance to ezetimibe or atorvastatin
• Patient with diabetes or coronary heart disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 79 Years

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 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00276458

Study ID Number: 2005_104

ClinicalTrials.gov Identifier: NCT00276458

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site