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NCT00171262 Clinical Trial

Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Dyslipidemia Clinical Trial

Official title:
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171262
Other study ID # CXUO320BES02
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated February 20, 2017
Start date August 2004
Est. completion date June 2007

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin

Locations
Country Name City State
Spain Novartis Madrid

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in serum inflammatory markers after 52 weeks
Secondary Change from baseline in fibrosis parameters and endothelial function after 52 weeks
Secondary Adverse events and serious adverse events after 52 weeks
Secondary Change from baseline in laboratory tests of kidney function after 12 weeks
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