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The Effect of Fluvastatin Treatment in Patients With Metabolic Syndrome
This study has been completed.
First Received: April 21, 2008   Last Updated: August 11, 2009   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00664742
  Purpose

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


Condition Intervention Phase
Metabolic Syndrome
 Drug: fluvastatin
 Phase IV

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: The Effect of Fluvastatin Treatment on the Lipid Profile in Patients With Metabolic Syndrome

Resource links provided by NLM:

Drug Information available for: Fluvastatin
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in TC, HDL-C, LDL-C and TG levels from baseline to week-6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients achieving TC LDL-C HDL-C TG target [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adverse events, serious adverse events; safety laboratory assessments [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
1: Experimental Drug: fluvastatin
Fluvastatin extended release 80 mg

  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 (NCEP ATP III criteria)
  • TG < 400 mg/dl and 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: Novartis Pharmaceuticals ( Medical Affairs )
Study ID Numbers: CXUO320BTR03
Study First Received: April 21, 2008
Last Updated: August 11, 2009
ClinicalTrials.gov Identifier: NCT00664742     History of Changes
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
 Syndrome
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Fluvastatin

ClinicalTrials.gov processed this record on February 08, 2010



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