The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00664742

Purpose

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

Condition	Intervention	Phase
Metabolic Syndrome	Drug: Fluvastatin XL®	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Metabolic Syndrome

Drug Information available for: Fluvastatin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 [ Time Frame: Baseline,6 weeks ] [ Designated as safety issue: No ]
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:

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 [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
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.

Enrollment:	614
Study Start Date:	September 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluvastatin XL® Treatment 80 mg once daily, at bedtime.	Drug: Fluvastatin XL® Fluvastatin extended release 80 mg Other Name: Lescol XL

Eligibility

Ages Eligible for Study:	20 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664742

Locations

Turkey
Götzepe Education and Research Hospital
Istanbul, Turkey

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Medical Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00664742 History of Changes
Other Study ID Numbers:	CXUO320BTR03
Study First Received:	April 21, 2008
Results First Received:	January 5, 2011
Last Updated:	April 19, 2011
Health Authority:	Turkey: Ministry of Health

Keywords provided by Novartis:

Metabolic syndrome,dyslipidemia,fluvastatin extended release

Additional relevant MeSH terms:

Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012