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

Phase 4

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: Fluvastatin XL®

• Registration Number: NCT00664742
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Results First Submitted: 2011-01-05
• Status Verified: 2011-04
• Results First Submitted QC: 2011-04-19
• Last Update Submitted: 2011-04-19
• Results First Posted: 2011-05-17
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluvastatin XL® Treatment	Fluvastatin XL®	80 mg once daily, at bedtime.

Primary Outcome Measures

Name	Time	Method
Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6	Baseline,6 weeks	Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels	Baseline, 6 weeks	The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC \<200 mg/dL, LDL-C \<100 mg/dL, HDL-C \>=60 mg/dL and TG \< 150 mg/dL.

Trial Locations

Locations (1)

Götzepe Education and Research Hospital; 🇹🇷 Istanbul, Turkey