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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: April 21, 2008
Last updated: April 19, 2011
Last verified: April 2011
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 4

Study Type: Interventional
Study Design: 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:

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 ]
    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 ]
    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


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00664742

Götzepe Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
  More Information

Responsible Party: Medical Affairs, Novartis Pharmaceuticals 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

Keywords provided by Novartis:
Metabolic syndrome,dyslipidemia,fluvastatin extended release

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 16, 2017