Skip to main content
OpenTrials
Completed

NCT Number: NCT00171262

Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Chronic Disease Disease Attributes Dyslipidemias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluvastatin

Drug

Primary outcomes

  1. Change from baseline in serum inflammatory markers after 52 weeks

Secondary outcomes

  1. Change from baseline in fibrosis parameters and endothelial function after 52 weeks

  2. Adverse events and serious adverse events after 52 weeks

  3. Change from baseline in laboratory tests of kidney function after 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.