Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome

Phase 4

Completed

• Conditions: Metabolic Syndrome
• Interventions: Drug: rosuvastatin

• Registration Number: NCT00815659
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-29
• Study First Posted: 2008-12-30
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-03-24
• Results First Submitted QC: 2011-06-07
• Results First Posted: 2011-07-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	rosuvastatin	medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Total Cholesterol Level	Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)	Baseline
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal HDL-cholesterol Level	Baseline	HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-cholesterol Level	Baseline	LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Basal Triglyceride Level	Baseline	Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Triglyceride Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \<100 mg/dL; HDL-cholesterol: For males \>40 mg/dL, for females \>50 mg/dL; non-HDL-cholesterol: \<130 mg/dL
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment

Secondary Outcome Measures

Name	Time	Method
Basal Intermediate HDL Subfraction Level	Baseline	Intermediate HDL subfraction levels before (Visit 2-enrollment)
Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Small HDL Subfraction Level	Baseline	Small HDL subfraction levels before (Visit 2-enrollment)
Basal Interleukin 1 (IL-1) Level	Baseline	IL-1 levels before (Visit 2-enrollment)
Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Interleukin 6 (IL-6) Level	Baseline	IL-6 levels before (Visit 2-enrollment)
Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Interleukin 8 (IL-8) Level	Baseline	IL-8 levels before (Visit 2-enrollment)
Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Interleukin 10 (IL-10) Level	Baseline	IL-10 levels before (Visit 2-enrollment)
Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Tumor Necrosis Factor (TNF) Level	Baseline	TNF levels before (Visit 2-enrollment)
Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level	Baseline	hs-CRP levels before (Visit 2-enrollment)
High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-3 Level	Baseline	LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls
LDL-3 Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-4 Level	Baseline	LDL-4 levels before (Visit 2-enrollment)
LDL-4 Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-5 Level	Baseline	LDL-5 levels before (Visit 2-enrollment)
LDL-5 Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-6 Level	Baseline	LDL-6 levels before (Visit 2-enrollment)
LDL-6 Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-7 Level	Baseline	LDL-7 levels before (Visit 2-enrollment)
LDL-7 Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Large HDL Subfraction Level	Baseline	Large HDL subfraction levels before (Visit 2-enrollment)
Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	3 months (from enrollment to last visit)	Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Number of Patients With Adverse Events	3 months (from enrollment to last visit)	Number of patients with any adverse events in 3 months of rosuvastatin treatment

Trial Locations

Locations (2)

Research site; 🇹🇷 Kocaeli, Umuttepe, Turkey

Research Site; 🇹🇷 Trabzon, Turkey