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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
History of Changes
  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:

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

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 June 17, 2013