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

0653A-134

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.

2008-11-01

2010-09-01

2010-09-01

Completed

Early phase I

250

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ACTUAL'}}

2024-05-16