Official Title: “Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome”

Other effects of fluvastatin are investigated in German patients with metabolic syndrome.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin

Primary Measures

• Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks

Secondary Measures

• Change from baseline in low density lipoprotein cholesterol after 5 weeks
• Change from baseline in non high density lipoprotein cholesterol after 5 weeks
• Change from baseline in total cholesterol after 5 weeks
• Change from baseline in high density lipoprotein cholesterol after 5 weeks
• Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks

Inclusion Criteria:

• Written informed consent
• Male and female patients, aged between 18 and 75 years
• Metabolic syndrome according to National Cholesterol Education Program Adult Treatment
• Panel III (NCEP ATPIII)

Exclusion Criteria:

• History of heart failure
• HIV positive
• Stroke
• Other protocol defined inclusion and 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

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00138528

Study ID Number: CXUO320BDE30

ClinicalTrials.gov Identifier: NCT00138528

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