Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Phase 4

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT00138528
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-30
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks
Change from baseline in non high density lipoprotein cholesterol after 5 weeks
Change from baseline in high density lipoprotein cholesterol after 5 weeks
Change from baseline in low density lipoprotein cholesterol after 5 weeks
Change from baseline in total cholesterol after 5 weeks

Trial Locations

Locations (1)

Novartis; 🇩🇪 Nürnberg, Germany