Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

This study has been completed.

First Received: September 12, 2005 Last Updated: March 20, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171262

Purpose

To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing certain inflammatory markers. In addition, tolerability and safety will also be evaluated in a Spanish population.

Condition	Intervention	Phase
Dyslipidemia	Drug: Fluvastatin	Phase IV

Drug Information available for: Fluvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in serum inflammatory markers after 52 weeks

Secondary Outcome Measures:

Change from baseline in fibrosis parameters and endothelial function after 52 weeks
Adverse events and serious adverse events after 52 weeks
Change from baseline in laboratory tests of kidney function after 12 weeks

Estimated Enrollment:	120
Study Start Date:	August 2004

Eligibility

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

Criteria

Inclusion Criteria:

Patients > 18 years Patients that give their inform consent

Exclusion Criteria:

Pregnant women Diabetic patients Treated with statins for the year prior to study inclusion Patients with contraindications listed in fluvastatin prescribing information

Other protocol-defined in and exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171262

Locations

Spain
Novartis
Madrid, Spain

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CXUO320BES02
Study First Received:	September 12, 2005
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00171262 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

Dyslipidemia, chronic renal disease, fluvastatin

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Renal Insufficiency, Chronic
Antilipemic Agents
Kidney Failure, Chronic
Anticholesteremic Agents

Kidney Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Fluvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Fluvastatin
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009