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

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ClinicalTrials.gov Identifier: NCT00664742
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : May 17, 2011
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Novartis

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Fluvastatin XL® Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome
Study Start Date : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007


Arm Intervention/treatment
Experimental: Fluvastatin XL® Treatment
80 mg once daily, at bedtime.
Drug: Fluvastatin XL®
Fluvastatin extended release 80 mg
Other Name: Lescol XL



Primary Outcome Measures :
  1. 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 :
  1. 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.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664742


Locations
Turkey
Götzepe Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Novartis

Responsible Party: Medical Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00664742     History of Changes
Other Study ID Numbers: CXUO320BTR03
First Posted: April 23, 2008    Key Record Dates
Results First Posted: May 17, 2011
Last Update Posted: May 17, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Fluvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors