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Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00171262
Enrollment
120
Registered
2005-09-15
Start date
2004-08-31
Completion date
2007-06-30
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Dyslipidemia, chronic renal disease, fluvastatin

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.

Interventions

DRUGFluvastatin

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Change from baseline in serum inflammatory markers after 52 weeks

Secondary

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026