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

A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome

This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.

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.