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 High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg”

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: atorvastatin
  • Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks
• Drug: atorvastatin
  • Atorvastatin 40 mg by mouth, once a day for 6 weeks
• Drug: ezetimibe
  • Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Atorvastatin 80 mg
• Experimental: 2
  • Atorvastatin 40 mg + ezetimibe 10 mg

Primary Measures

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

Secondary Measures

• Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
  • Time Frame: Baseline and 6 weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Total-Cholesterol
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Triglycerides (TG)
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
  • Time Frame: Baseline and 6 Weeks
    Safety Issue?: No
• Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg

Exclusion Criteria:

• Pregnant or lactating women or intending to become pregnant
• Patient with sensitivity or intolerance to ezetimibe or atorvastatin

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 Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00276484

Study ID Number: 2005_105

ClinicalTrials.gov Identifier: NCT00276484

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

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