NCT00171262CompletedPhase 4
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change from baseline in serum inflammatory markers after 52 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from baseline in serum inflammatory markers after 52 weeks
Secondary Outcomes
- 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
Investigators
Study Sites (1)
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