The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Fluvastatin

Criteria

Inclusion Criteria:

• ≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)

• Triglyceride (TG) < 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl

• Written informed consent for participating in the study

Exclusion Criteria:

• Severe renal disease or renal dysfunction

• Chronic liver disease or liver function impairment

• Inflammatory muscle dysfunction or findings of muscle problems

• Severe cardiac failure

Other protocol defined inclusion exclusion criteria may apply