Phase 4
N=607
The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00664742 ↗Enrolled (actual)
607
Serious AEs
0.3%
Results posted
May 2011
Primary outcome: 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 — -50.4; -0.6; -45.2; -22.3 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluvastatin XL® (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-50.4; -0.6; -45.2; -22.3 | — |
| 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 |
22.4; 64.9; 0.7; 51.2; 13.7; 10.0 | — |
Summary
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00664742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.