Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00138528
First received: August 25, 2005
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Metabolic Syndrome
Drug: Fluvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome 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

Enrollment: 55
Study Start Date: October 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138528

Locations
Germany
Novartis
Nürnberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00138528     History of Changes
Other Study ID Numbers: CXUO320BDE30
Study First Received: August 25, 2005
Last Updated: November 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Metabolic Syndrome, fluvastatin

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 16, 2014