The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT00664742|
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : May 17, 2011
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Drug: Fluvastatin XL®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||614 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Experimental: Fluvastatin XL® Treatment
80 mg once daily, at bedtime.
Drug: Fluvastatin XL®
Fluvastatin extended release 80 mg
Other Name: Lescol XL
- 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 [ Time Frame: Baseline,6 weeks ]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.
- 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 [ Time Frame: Baseline, 6 weeks ]The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664742
|Götzepe Education and Research Hospital|