Back to resultsOther Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Fluvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, fluvastatin
Eligibility Criteria
Inclusion Criteria: Written informed consent Male and female patients, aged between 18 and 75 years Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) Exclusion Criteria: History of heart failure HIV positive Stroke Other protocol defined inclusion and exclusion criteria may apply.
Sites / Locations
- Novartis
Outcomes
Primary Outcome Measures
Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks
Secondary Outcome Measures
Change from baseline in low density lipoprotein cholesterol after 5 weeks
Change from baseline in non high density lipoprotein cholesterol after 5 weeks
Change from baseline in total cholesterol after 5 weeks
Change from baseline in high density lipoprotein cholesterol after 5 weeks
Change from baseline in oxidized low density lipoprotein cholesterol after 5 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00138528
Brief Title
Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
Official Title
Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Other effects of fluvastatin are investigated in German patients with metabolic syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, fluvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fluvastatin
Primary Outcome Measure Information:
Title
Change from baseline in circulating marker of inflammation (C-reactive protein) after 5 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in low density lipoprotein cholesterol after 5 weeks
Title
Change from baseline in non high density lipoprotein cholesterol after 5 weeks
Title
Change from baseline in total cholesterol after 5 weeks
Title
Change from baseline in high density lipoprotein cholesterol after 5 weeks
Title
Change from baseline in oxidized low density lipoprotein cholesterol after 5 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:
Written informed consent
Male and female patients, aged between 18 and 75 years
Metabolic syndrome according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII)
Exclusion Criteria:
History of heart failure
HIV positive
Stroke
Other protocol defined inclusion 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
Nürnberg
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18413332
Citation
Westphal S, Abletshauser C, Luley C. Fluvastatin treatment and withdrawal: effects on endothelial function. Angiology. 2008 Oct-Nov;59(5):613-8. doi: 10.1177/0003319708316005. Epub 2008 Apr 14.
Results Reference
result
Learn more about this trial
Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome
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