Official Title: “A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD”

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: ezetimibe
  • ezetimibe 10 mg daily for 12 weeks.
• Drug: Comparator: atorvastatin calcium
  • atorvastatin 10 mg; atorvastatin 20 mg. In Week 6, atorvastatin will be titrated up: atorvastatin 40 mg. Daily for 12 weeks.
• Drug: Comparator: Placebo (unspecified)
  • ezetimibe 10 mg pbo daily for 12 weeks
• Drug: Comparator: Placebo (unspecified)
  • atorvastatin 10 mg pbo; atorvastatin 20 mg pbo. In Week 6, atorvastatin will be titrated up: atorvastatin 40 mg pbo. daily for 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Drug
• Active Comparator: 2
  • active comparator

Primary Measures

• LDL levels
  • Time Frame: After 6 weeks of treatment
    Safety Issue?: No

Secondary Measures

• LDL levels
  • Time Frame: After 12 weeks of treatment
    Safety Issue?: No
• Percent of patients reaching pre-specified LDL levels
  • Time Frame: After 6 & 12 weeks of treatment
    Safety Issue?: No
• Other lipid parameters
  • Time Frame: After 6 & 12 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Patient is age 65 or older
• Patient is willing to maintain cholesterol lowering diet
• Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category

Exclusion Criteria:

• A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study
• Patient is unlikely to be compliant in taking study medication
• Patient with chronic or unstable medical condition
• Patient is taking unstable doses of medication
• Patient drinks more than 2 alcoholic drinks per day
• Patient has elevations in certain laboratory values (CK, AST, ALT)

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 Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00418834

Study ID Number: 2006_549

ClinicalTrials.gov Identifier: NCT00418834

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)