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

Verified by: Novartis, April 2011
First Received: April 21, 2008 | Last Updated: April 19, 2011 | Phase: Phase 4 | Start Date: September 2006
Overall Status: Completed | Estimated Enrollment: 614
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This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic...

Brief Summary

Official Title: “The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome”

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

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

  • Drug: Fluvastatin XL®
    • Fluvastatin extended release 80 mg

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Fluvastatin XL® Treatment
    • 80 mg once daily, at bedtime.

Outcome Measures for this Clinical Trial

Primary 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
      Safety Issue?: No

Secondary 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novartis Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664742

Study ID Number: CXUO320BTR03

ClinicalTrials.gov Identifier: NCT00664742

Health Authority: Turkey: Ministry of Health

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00664742