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

The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00664742
Enrollment
614
Registered
2008-04-23
Start date
2006-09-30
Completion date
2007-10-31
Last updated
2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome,dyslipidemia,fluvastatin extended release

Brief summary

This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome

Interventions

DRUGFluvastatin XL®

Fluvastatin extended release 80 mg

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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-6Baseline,6 weeksMean 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.

Secondary

MeasureTime frameDescription
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 LevelsBaseline, 6 weeksThe 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.

Countries

Turkey (Türkiye)

Participant flow

Pre-assignment details

614 participants enrolled. 607 participants treated.

Participants by arm

ArmCount
Fluvastatin XL® Treatment
80 mg once daily, at bedtime.
607
Total607

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up92
Overall StudyWithdrawal by Subject31
Overall StudyWithdrawn due to adverse events3

Baseline characteristics

CharacteristicFluvastatin XL® Treatment
Age Continuous54 years
STANDARD_DEVIATION 10
Sex/Gender, Customized
Female
421 participants
Sex/Gender, Customized
Gender not recorded
3 participants
Sex/Gender, Customized
Male
183 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 607
serious
Total, serious adverse events
2 / 607

Outcome results

Primary

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

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Fluvastatin XL® TreatmentChange in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6Change in TC-50.4 mg/dL95% Confidence Interval 28.99897
Fluvastatin XL® TreatmentChange in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6Change in HDL-C-0.6 mg/dL95% Confidence Interval 12.30119
Fluvastatin XL® TreatmentChange in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6Change in LDL-C-45.2 mg/dL95% Confidence Interval 62.92132
Fluvastatin XL® TreatmentChange in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6Change in TG-22.3 mg/dL95% Confidence Interval 71.50801
Secondary

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

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

Population: This analysis was done on the safety population which consists of all participants who received at least one dose of study medication.

ArmMeasureGroupValue (NUMBER)
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsHDL-C >= 60 mg/dL at Baseline13.7 Percentage of Participants
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsTC<200 mg/dL at Baseline22.4 Percentage of Participants
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsTC<200 mg/dL at Week-664.9 Percentage of Participants
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsLDL-C < 100 mg/dL at Baseline0.7 Percentage of Participants
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsLDL-C < 100 mg/dL at Week-651.2 Percentage of Participants
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsHDL-C >= 60 mg/dL at Week-610.0 Percentage of Participants
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsTG < 150 mg/dL at Baseline33.6 Percentage of Participants
Fluvastatin XL® TreatmentPercentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid LevelsTG < 150 mg/dL at Week-639.5 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026