Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)

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.

Intervention(s) in this Clinical Trial

• Drug: ezetimibe and atorvastatin
  • ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks
• Drug: atorvastatin
  • Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks
• Drug: Placebo (unspecified)
  • Placebo (unspecified) daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2

Primary Measures

• Percent Change From Baseline in LDL-C at Week 6
  • Time Frame: Baseline and Week 6
    Safety Issue?: No

Secondary Measures

• Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
  • Time Frame: Week 6
    Safety Issue?: No
• Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12
  • Time Frame: Week 12
    Safety Issue?: No
• Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6
  • Time Frame: Week 6
    Safety Issue?: No
• Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12
  • Time Frame: Week 12
    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 Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

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)

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