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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00664742
First received: April 21, 2008
Last updated: April 19, 2011
Last verified: April 2011
  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 4

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:


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 April 17, 2014