A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and not at their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Participant is currently taking a stable dose of lipid lowering agent(s). (if applicable) or is statin naive

• Participant is currently taking a stable dose of lipid lowering agent(s). (if is at least moderate high risk for Coronary Heart Disease (CHD))

• Participant is currently taking a stable dose of lipid lowering agent(s). (if is willing to maintain Therapeutic Lifestyle Changes (TLC) / American Diabetes Association(ADA) diet)

Exclusion Criteria:

• Participant weighs less than 100 lbs (45 kg).

• Participant has hypersensitivity or intolerance to ezetimibe, or rosuvastatin or any components of these medications.

• If female, participant is pregnant or breastfeeding.

• Participant consumes more than 2 alcoholic beverages per day.

• Participant has been in a clinical trial within the last 30 days.

• Participant has heart problems such as CHF, unstable angina or heart attack.

• Participant has type 1 or 2 diabetes and has changed their medication in the last 2 months.

• Participant has liver disease.

• Participant is Human Immunodeficiency Virus (HIV) positive.

• Participant has a history of drug or alcohol abuse in the last year.