Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome

Inclusion criteria

• Written informed consent to participate in the study prior to any study procedures.
• Male or female subjects, age between 18-75 years inclusive.
• All women of child bearing potential must have a negative pregnancy test
• Metabolic Syndrome according to the International Diabetes Federation definition:

• Low plasma HDL-C (Men < 40 mg/dl ; Women < 50 mg/dl ).
• Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
• And one or more of the following criteria:

• Triglycerides ≥ 150 mg/d.l
• Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
• Fasting plasma glucose≥ 100mg/dl.
• Previously diagnosed type 2 diabetes.

Exclusion criteria

• Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
• Type 1 diabetes.
• HbA1c > 9.5%.
• Unexplained serum creatine phosphokinase > 2 x Upper limit of normal.
• History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
• Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.

Other protocol-defined inclusion/exclusion criteria may apply.