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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: June 2007
Intervention(s) in this Clinical Trial
- Drug: Fluvastatin
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171262
