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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

Page last updated: August 23, 2015

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