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Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

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ClinicalTrials.gov Identifier: NCT00171262
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Fluvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Study Start Date : August 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  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


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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171262


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

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171262     History of Changes
Other Study ID Numbers: CXUO320BES02
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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

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