Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Phase 4

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT00171262
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum inflammatory markers after 52 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novartis; 🇪🇸 Madrid, Spain