Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171262
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171262

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171262     History of Changes
Other Study ID Numbers: CXUO320BES02
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014