Official Title: “The Effect of Fluvastatin Treatment on the Lipid Profile in Patients With Metabolic Syndrome”

This study will evaluate the safety, efficacy and tolerability of fluvastatin extended release (80 mg once daily) in patients with metabolic syndrome

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: fluvastatin
  • 80 mg once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Change from baseline in total cholesterol levels at 6 weeks
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Adverse Events
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female patients > 20 years of age
• Patients meeting at least three criteria for metabolic syndrome
• Triglycerides levels < 400 mg/dl and LDL cholesterol levels between 100 mg/dl and 190 mg/dl
• Written consent for participating in the study
• Patients who are able to communicate and able to follow all the requirements

Exclusion Criteria:

• Patients with severe renal disease or renal dysfunction
• Patients with chronic liver disease or liver function impairment
• Patients with inflammatory muscle dysfunction or findings of muscle problems
• Patients with severe cardiac failure
• Patients with findings of any cardiovascular event within the last 6 months Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664742

Study ID Number: CXUO320BTR03

ClinicalTrials.gov Identifier: NCT00664742

Health Authority: Turkey: Ministry of Health