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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes
Fluvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014