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

Metabolic Syndrome Clinical Trial

Official title:

The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664742
• Other study ID #: CXUO320BTR03
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2008
• Last updated: April 19, 2011
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Fluvastatin XL®
Fluvastatin extended release 80 mg

Locations

Country	Name	City	State
Turkey	Götzepe Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline,6 weeks	No
Secondary	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	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.	Baseline, 6 weeks	No