Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00138528

Purpose

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

Condition	Intervention	Phase
Metabolic Syndrome	Drug: Fluvastatin	Phase IV

Drug Information available for: Fluvastatin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

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

Estimated Enrollment:	50
Study Start Date:	October 2004

Eligibility

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:

Other protocol defined inclusion and exclusion criteria may apply.

Contacts and Locations

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

Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CXUO320BDE30
Study First Received:	August 25, 2005
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00138528
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Metabolic Syndrome, fluvastatin

Study placed in the following topic categories:

Fluvastatin

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

ClinicalTrials.gov processed this record on January 16, 2009