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The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00664742
Recruitment Status : Completed
First Posted : April 23, 2008
Results First Posted : May 17, 2011
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metabolic Syndrome
Intervention Drug: Fluvastatin XL®
Enrollment 614
Recruitment Details  
Pre-assignment Details 614 participants enrolled. 607 participants treated.
Arm/Group Title Fluvastatin XL® Treatment
Hide Arm/Group Description 80 mg once daily, at bedtime.
Period Title: Overall Study
Started 607
Completed 481
Not Completed 126
Reason Not Completed
Withdrawn due to adverse events             3
Withdrawal by Subject             31
Lost to Follow-up             92
Arm/Group Title Fluvastatin XL® Treatment
Hide Arm/Group Description 80 mg once daily, at bedtime.
Overall Number of Baseline Participants 607
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 607 participants
54  (10)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 607 participants
Female 421
Male 183
Gender not recorded 3
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline,6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Per Protocol Population which consists of all participants who did not violate inclusion/ exclusion criteria, completed the treatment study phase or withdrew from the study due to progression, death, or toxicity (AE related to study drug) and had at least one key response evaluation.
Arm/Group Title Fluvastatin XL® Treatment
Hide Arm/Group Description:
80 mg once daily, at bedtime.
Overall Number of Participants Analyzed 481
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Change in TC
-50.4
(-53.4 to -47.5)
Change in HDL-C
-0.6
(-1.4 to 0.2)
Change in LDL-C
-45.2
(-47.7 to -42.8)
Change in TG
-22.3
(-27.9 to -16.7)
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the safety population which consists of all participants who received at least one dose of study medication.
Arm/Group Title Fluvastatin XL® Treatment
Hide Arm/Group Description:
80 mg once daily, at bedtime.
Overall Number of Participants Analyzed 607
Measure Type: Number
Unit of Measure: Percentage of Participants
TC<200 mg/dL at Baseline 22.4
TC<200 mg/dL at Week-6 64.9
LDL-C < 100 mg/dL at Baseline 0.7
LDL-C < 100 mg/dL at Week-6 51.2
HDL-C >= 60 mg/dL at Baseline 13.7
HDL-C >= 60 mg/dL at Week-6 10.0
TG < 150 mg/dL at Baseline 33.6
TG < 150 mg/dL at Week-6 39.5
Time Frame 6 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluvastatin XL® Treatment
Hide Arm/Group Description 80 mg once daily, at bedtime.
All-Cause Mortality
Fluvastatin XL® Treatment
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Fluvastatin XL® Treatment
Affected / at Risk (%)
Total   2/607 (0.33%) 
Cardiac disorders   
Coronary Artery Bypass Surgery  1  1/607 (0.16%) 
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis and Myalgia  1  1/607 (0.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluvastatin XL® Treatment
Affected / at Risk (%)
Total   0/607 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Medical Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00664742    
Other Study ID Numbers: CXUO320BTR03
First Submitted: April 21, 2008
First Posted: April 23, 2008
Results First Submitted: January 5, 2011
Results First Posted: May 17, 2011
Last Update Posted: May 17, 2011