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

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

Official Title
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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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: Fluvastatin extended release, fenofibrate
* Drug: Fixed combination simvastatin/ezetimibe


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluvastatin extended release, fenofibrate|nan|
|Drug: Fixed combination simvastatin/ezetimibe|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High density lipoprotein cholesterol (HDL-C) measured at the end of each study period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared at the end of each treatment period: |  |  | 
| patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl |  |  | 
| patients reaching target levels of non-HDL-C <130mg/ |  |  | 
| LDL-C/HDL-C |  |  | 
| Triglycerides |  |  | 
| LDL subfractions in a subgroup of patients |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, metabolic syndrome, fluvastatin, fenofibrate, simvastatin, ezetimibe