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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Ezetimibe; Fenofibrate; Fluvastatin; Simvastatin

Criteria

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.