Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin extended release, fenofibrate
• Drug: Fixed combination simvastatin/ezetimibe

Primary Measures

• High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma AG Study Director Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00385658

Study ID Number: CXUO320BDE35

ClinicalTrials.gov Identifier: NCT00385658

Health Authority: Germany: Federal Institute for Drugs and Medical Devices