The Effect of Fluvastatin XL� Treatment in Patients With Metabolic Syndrome
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: Fluvastatin XL® (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis
Summary
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® - extended release
(80 mg once daily) in patients with metabolic syndrome
Clinical Details
Official title: The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: 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
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ≥ 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 Criteria:
- 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
Locations and Contacts
Götzepe Education and Research Hospital, Istanbul, Turkey
Additional Information
Starting date: September 2006
Last updated: April 19, 2011
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