The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome
1 other identifier
interventional
614
1 country
1
Brief Summary
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 21, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedResults Posted
Study results publicly available
May 17, 2011
CompletedMay 17, 2011
April 1, 2011
1.1 years
April 21, 2008
January 5, 2011
April 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6
Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.
Baseline,6 weeks
Secondary Outcomes (1)
Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels
Baseline, 6 weeks
Study Arms (1)
Fluvastatin XL® Treatment
EXPERIMENTAL80 mg once daily, at bedtime.
Interventions
Fluvastatin extended release 80 mg
Eligibility Criteria
You may qualify if:
- ≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)
- Triglyceride (TG) \< 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl
- Written informed consent for participating in the study
You may not qualify if:
- Severe renal disease or renal dysfunction
- Chronic liver disease or liver function impairment
- Inflammatory muscle dysfunction or findings of muscle problems
- Severe cardiac failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Götzepe Education and Research Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2008
First Posted
April 23, 2008
Study Start
September 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
May 17, 2011
Results First Posted
May 17, 2011
Record last verified: 2011-04