Official Title: “Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin

Primary Measures

• Change from baseline in serum inflammatory markers after 52 weeks

Secondary 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

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

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

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171262

Study ID Number: CXUO320BES02

ClinicalTrials.gov Identifier: NCT00171262

Health Authority: Spain: Spanish Agency of Medicines