Back to resultsTrial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Fluvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia, chronic renal disease, fluvastatin
Eligibility 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
Sites / Locations
- Novartis
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171262
Brief Title
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Official Title
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Dyslipidemia, chronic renal disease, fluvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluvastatin
Primary Outcome Measure Information:
Title
Change from baseline in serum inflammatory markers after 52 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in fibrosis parameters and endothelial function after 52 weeks
Title
Adverse events and serious adverse events after 52 weeks
Title
Change from baseline in laboratory tests of kidney function after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis
City
Madrid
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
We'll reach out to this number within 24 hrs