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Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 12, 2005
Last updated: February 20, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Dyslipidemia Drug: Fluvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in serum inflammatory markers after 52 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 120
Study Start Date: August 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00171262

Madrid, Spain
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT00171262     History of Changes
Other Study ID Numbers: CXUO320BES02
Study First Received: September 12, 2005
Last Updated: February 20, 2017

Keywords provided by Novartis:
Dyslipidemia, chronic renal disease, fluvastatin

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 22, 2017