Phase 4
Completed N=97
Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
Source: ClinicalTrials.gov NCT00815659 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Basal HDL-cholesterol Level — 39.5 mg/dL
Summary
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Basal HDL-cholesterol Level |
39.5 | — |
| PRIMARY HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment |
43.4 | — |
| PRIMARY Basal LDL-cholesterol Level |
165.5 | — |
| PRIMARY LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment |
98.3 | — |
| PRIMARY Basal Total Cholesterol Level |
236.5 | — |
| PRIMARY Total Cholesterol Level After 3 Months of Rosuvastatin Treatment |
166.2 | — |
| PRIMARY Basal Triglyceride Level |
195.1 | — |
| PRIMARY Triglyceride Level After 3 Months of Rosuvastatin Treatment |
153.1 | — |
| PRIMARY Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment |
48 | — |
| PRIMARY Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment |
39 | — |
| PRIMARY Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment |
51 | — |
| SECONDARY Basal Interleukin 1 (IL-1) Level |
4.1 | — |
| SECONDARY Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment |
4.1 | — |
| SECONDARY Basal Interleukin 6 (IL-6) Level |
2.6 | — |
| SECONDARY Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment |
2.8 | — |
| SECONDARY Basal Interleukin 8 (IL-8) Level |
10.7 | — |
| SECONDARY Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment |
12.7 | — |
| SECONDARY Basal Interleukin 10 (IL-10) Level |
4.2 | — |
| SECONDARY Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment |
4.8 | — |
| SECONDARY Basal Tumor Necrosis Factor (TNF) Level |
10.8 | — |
| SECONDARY Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment |
12.9 | — |
| SECONDARY Basal High Sensitivity C-reactive Protein (Hs-CRP) Level |
8.2 | — |
| SECONDARY High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment |
6.7 | — |
| SECONDARY Basal LDL-3 Level |
15.5 | — |
| SECONDARY LDL-3 Level After 3 Months of Rosuvastatin Treatment |
8.8 | — |
| SECONDARY Basal LDL-4 Level |
7.9 | — |
| SECONDARY LDL-4 Level After 3 Months of Rosuvastatin Treatment |
3.5 | — |
| SECONDARY Basal LDL-5 Level |
2.7 | — |
| SECONDARY LDL-5 Level After 3 Months of Rosuvastatin Treatment |
1.3 | — |
| SECONDARY Basal LDL-6 Level |
0.5 | — |
| SECONDARY LDL-6 Level After 3 Months of Rosuvastatin Treatment |
0.3 | — |
| SECONDARY Basal LDL-7 Level |
0.5 | — |
| SECONDARY LDL-7 Level After 3 Months of Rosuvastatin Treatment |
0.8 | — |
| SECONDARY Basal Large HDL Subfraction Level |
15.0 | — |
| SECONDARY Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment |
17.6 | — |
| SECONDARY Basal Intermediate HDL Subfraction Level |
18.9 | — |
| SECONDARY Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment |
19.9 | — |
| SECONDARY Basal Small HDL Subfraction Level |
6.2 | — |
| SECONDARY Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment |
6.6 | — |
| SECONDARY Number of Patients With Adverse Events |
24 | — |
Eligibility Criteria
Inclusion Criteria
- metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
- LDL-Cholesterol > 130mg/dl
- HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females
- Triglycerides < 400 mg/dl
Exclusion Criteria
- With a concomitant coronary disease
- Currently under statin therapy or previously treated with statins within the last 6 months
Data sourced from ClinicalTrials.gov (NCT00815659). 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. Informational only — not medical advice.