A Phase 4 interventional study of Fluvastatin XL® in Metabolic Syndrome, sponsored by Novartis. Completed at 1 site in Turkey. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-05-17.
Sponsored by Novartis · Phase 4, Interventional, and Treatment
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 614 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol defined inclusion exclusion criteria may apply
80 mg once daily, at bedtime.
Drug: Fluvastatin XL®
Fluvastatin extended release 80 mg
Also known as: 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
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
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
| Milestone | Fluvastatin XL® Treatment |
|---|---|
| Started | 607 |
| Completed | 481 |
| Not completed | 126 |
| Withdrew: Withdrawn due to adverse events | 3 |
| Withdrew: Withdrawal by subject | 31 |
| Withdrew: Lost to follow-up | 92 |
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.
| mg/dL | Fluvastatin XL® Treatment |
|---|---|
| Change in TC | -50.4 ± 28.99897 |
| Change in HDL-C | -0.6 ± 12.30119 |
| Change in LDL-C | -45.2 ± 62.92132 |
| Change in TG | -22.3 ± 71.50801 |
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.
| Percentage of Participants | Fluvastatin XL® Treatment |
|---|---|
| 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 |
Collected over 6 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluvastatin XL® Treatment | — | 2/607 (0.3%) | 0/607 (0%) |
| Event | Fluvastatin XL® Treatment |
|---|---|
| Rhabdomyolysis and MyalgiaMusculoskeletal and connective tissue disorders | 1/607 |
| Coronary Artery Bypass SurgeryCardiac disorders | 1/607 |
| Age Continuous(years) | Fluvastatin XL® Treatment |
|---|---|
| Mean | 54 ± 10 |
| Sex/Gender, Customized(participants) | Fluvastatin XL® Treatment |
|---|---|
| Female | 421 |
| Male | 183 |
| Gender not recorded | 3 |
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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