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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

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