Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

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”

Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (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.

Intervention(s) in this Clinical Trial

• Drug: ezetimibe/simvastatin 10/40
  • ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.
• Drug: atorvastatin 40 mg
  • atorvastatin 40 mg tablet once daily for 6 weeks
• Drug: atorvastatin 20 mg
  • All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: ezetimibe/simvastatin 10/40
  • Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period
• Active Comparator: atorvastatin 40 mg
  • Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period

Primary Measures

• Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No

Secondary Measures

• Number of Participants Reaching LDL-C Target Goals of <70 mg/dL
  • Time Frame: Treatment Week 6
    Safety Issue?: No
• Number of Participants Reaching LDL-C Target Goal <77 mg/dL
  • Time Frame: Treatment Week 6
    Safety Issue?: No
• Number of Participants Reaching LDL-C Target Goal <100 mg/dL
  • Time Frame: Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Total Cholesterol
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Triglycerides
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Non-HDL Cholesterol
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Apolipoprotein B
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Apolipoprotein A-1
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in Apolipoprotein B/A-1 Ratio
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No
• Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
  • Time Frame: Baseline (Treatment Day 1), Treatment Week 6
    Safety Issue?: No

Inclusion Criteria:

• Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
• Participant meets Adult Treatment Panel (ATP) III High Risk criteria

Exclusion Criteria:

• Females who are pregnant or breastfeeding
• Participant consumes more than 14 alcoholic beverages per week
• Participant has been treated with an investigational drug within the last 30 days
• Participant has congestive heart failure (New York Heart Association [NYHA] Type III or IV)
• Participant has had gastric bypass
• Participant is newly diagnosed with type 1 or 2 diabetes
• Participant is Human Immunodeficiency Virus (HIV) positive
• Participant 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 Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00782184

Study ID Number: MK-0653A-134

ClinicalTrials.gov Identifier: NCT00782184

Health Authority: United States: Food and Drug Administration