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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: ezetimibe
  • Atorvastatin 20mg and ezetimibe 10mg tablets po qd. for 6 weeks.
• Drug: atorvastatin
  • Atorvastatin 40mg tablet po qd for 6 weeks.
• Drug: Comparator: Placebo (unspecified)
  • Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd. for 6 weeks.
• Drug: Comparator: Placebo (unspecified)
  • Atorvastatin 40mg Pbo tablets po qd. 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.
• Other: 2
  • Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd.

Primary Measures

• Change in LDL-C
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Change in other lipid variables
  • 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 Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on October 07, 2008

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)

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

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