The Effect of Fluvastatin Treatment in Patients With Metabolic Syndrome
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome
Intervention: fluvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis
Summary
This study will evaluate the safety, efficacy and tolerability of fluvastatin extended
release (80 mg once daily) in patients with metabolic syndrome
Clinical Details
Official title: The Effect of Fluvastatin Treatment on the Lipid Profile in Patients With Metabolic Syndrome
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in total cholesterol levels at 6 weeks
Secondary outcome: Adverse Events
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patients > 20 years of age
- Patients meeting at least three criteria for metabolic syndrome
- Triglycerides levels < 400 mg/dl and LDL cholesterol levels between 100 mg/dl and 190
mg/dl
- Written consent for participating in the study
- Patients who are able to communicate and able to follow all the requirements
Exclusion Criteria:
- Patients with severe renal disease or renal dysfunction
- Patients with chronic liver disease or liver function impairment
- Patients with inflammatory muscle dysfunction or findings of muscle problems
- Patients with severe cardiac failure
- Patients with findings of any cardiovascular event within the last 6 months Other
protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Götzepe Education and Research Hospital, Istanbul, Turkey
Additional Information
Starting date: September 2006
Ending date: October 2007
Last updated: April 22, 2008
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