Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Novartis120 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Dyslipidemia

Interventions

FluvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

Madrid, Spain

Outcomes

Primary Outcomes

Change from baseline in serum inflammatory markers after 52 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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