Status:
COMPLETED
The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
Lead Sponsor:
Novartis
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
Brief Summary
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome
Eligibility Criteria
Inclusion
- ≥ 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
Exclusion
- Severe renal disease or renal dysfunction
- Chronic liver disease or liver function impairment
- Inflammatory muscle dysfunction or findings of muscle problems
- Severe cardiac failure
- Other protocol defined inclusion exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT00664742
Start Date
September 1 2006
End Date
October 1 2007
Last Update
May 17 2011
Active Locations (1)
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1
Götzepe Education and Research Hospital
Istanbul, Turkey (Türkiye)