Official Title: “A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin”

Patients currently taking atorvastatin 20 mg will be switched to either atorvastatin 40mg or ezetimibe/simvastatin 10/40. After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

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: January 2011

Intervention(s) in this Clinical Trial

• Drug: Comparator: ezetimibe/simvastatin 10/40 mg
  • Ezetimibe/simvastatin 10/40 mg tablet once daily for 6 weeks.
• Drug: Comparator: atorvastatin 40 mg
  • Atorvastatin 40 mg tablet once daily for 6 weeks
• Drug: Comparator: atorvastatin 20 mg
  • All patients will take atorvastatin 20 mg tablet once daily for the 6 week period before randomization

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Ezetimibe/simvastatin 10/40 mg
• Active Comparator: 2
  • Atorvastatin 40 mg

Primary Measures

• percent reduction in low-density lipoprotein cholesterol (LDL-C)
  • Time Frame: at 6 weeks
    Safety Issue?: No

Secondary Measures

• Reduction in low-density lipoprotein cholesterol (LDL-C) to <70, <77, <100 mg/dL goals
  • Time Frame: at 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
• Patient meets ATP III High Risk criteria

Exclusion Criteria:

• Females who are pregnant or breastfeeding
• Patient consumes more than 14 alcoholic beverages per week
• Patient has been treated with an investigational drug within the last 30 days
• Patient has congestive heart failure (NYHA Type III or IV)
• Patient has congestive heart failure
• Patient has had gastric bypass
• Patient is newly diagnosed with type 1 or 2 diabetes
• Patient is HIV positive
• Patient has a history of drug or alcohol abuse within the last 5 years

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/NCT00782184

Study ID Number: 2008_576

ClinicalTrials.gov Identifier: NCT00782184

Health Authority: United States: Food and Drug Administration