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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE April 23, 2008
Results First Submitted Date  ICMJE January 5, 2011
Results First Posted Date  ICMJE May 17, 2011
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE September 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
Change from baseline in total cholesterol levels at 6 weeks [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
Adverse Events [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
Official Title  ICMJE The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome
Brief Summary This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE Drug: Fluvastatin XL®
Fluvastatin extended release 80 mg
Other Name: Lescol XL
Study Arms  ICMJE Experimental: Fluvastatin XL® Treatment
80 mg once daily, at bedtime.
Intervention: Drug: Fluvastatin XL®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2009)
614
Original Actual Enrollment  ICMJE
 (submitted: April 22, 2008)
878
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00664742
Other Study ID Numbers  ICMJE CXUO320BTR03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP