Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

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Other effects of fluvastatin are investigated in German patients with metabolic syndrome...

Brief Summary

Official Title: “Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome”

Other effects of fluvastatin are investigated in German patients with metabolic syndrome.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: February 2006

Intervention(s) in this Clinical Trial

  • Drug: Fluvastatin

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks

Secondary Measures

  • Change from baseline in low density lipoprotein cholesterol after 5 weeks
  • Change from baseline in non high density lipoprotein cholesterol after 5 weeks
  • Change from baseline in total cholesterol after 5 weeks
  • Change from baseline in high density lipoprotein cholesterol after 5 weeks
  • Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Written informed consent
  • Male and female patients, aged between 18 and 75 years
  • Metabolic syndrome according to National Cholesterol Education Program Adult
  • Treatment Panel III (NCEP ATPIII)

Exclusion Criteria:

  • History of heart failure
  • HIV positive
  • Stroke
  • Other protocol defined inclusion and exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00138528

Study ID Number: CXUO320BDE30

ClinicalTrials.gov Identifier: NCT00138528

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00138528