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

Metabolic Syndrome Clinical Trial

— EFFORT  

Official title:

Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815659
• Other study ID #: D3560L00079
• Status: Completed
• Phase: Phase 4
• First received: December 29, 2008
• Last updated: August 29, 2011
• Start date: December 2008
• Est. completion date: March 2010

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• rosuvastatin
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Locations

Country	Name	City	State
Turkey	Research site	Ankara	Besevler
Turkey	Research site	Istanbul	Haseki
Turkey	Research Site	Izmir
Turkey	Research site	Kayseri	Erciyes
Turkey	Research site	Kocaeli	Umuttepe
Turkey	Research Site	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal HDL-cholesterol Level	HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)	Baseline	No
Primary	HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment	HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Primary	Basal LDL-cholesterol Level	LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)	Baseline	No
Primary	LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment	LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Primary	Basal Total Cholesterol Level	Baseline	Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)	No
Primary	Total Cholesterol Level After 3 Months of Rosuvastatin Treatment	Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Primary	Basal Triglyceride Level	Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)	Baseline	No
Primary	Triglyceride Level After 3 Months of Rosuvastatin Treatment	Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Primary	Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment	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	3 months (from enrollment to last visit)	No
Primary	Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment	Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment	3 months (from enrollment to last visit)	No
Primary	Number of Patients Who Reached Target Level of Non-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)	No
Secondary	Basal Interleukin 1 (IL-1) Level	IL-1 levels before (Visit 2-enrollment)	Baseline	No
Secondary	Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment	IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal Interleukin 6 (IL-6) Level	IL-6 levels before (Visit 2-enrollment)	Baseline	No
Secondary	Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment	IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal Interleukin 8 (IL-8) Level	IL-8 levels before (Visit 2-enrollment)	Baseline	No
Secondary	Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment	IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal Interleukin 10 (IL-10) Level	IL-10 levels before (Visit 2-enrollment)	Baseline	No
Secondary	Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment	IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal Tumor Necrosis Factor (TNF) Level	TNF levels before (Visit 2-enrollment)	Baseline	No
Secondary	Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment	TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal High Sensitivity C-reactive Protein (Hs-CRP) Level	hs-CRP levels before (Visit 2-enrollment)	Baseline	No
Secondary	High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment	hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal LDL-3 Level	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	Baseline	No
Secondary	LDL-3 Level After 3 Months of Rosuvastatin Treatment	LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal LDL-4 Level	LDL-4 levels before (Visit 2-enrollment)	Baseline	No
Secondary	LDL-4 Level After 3 Months of Rosuvastatin Treatment	LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal LDL-5 Level	LDL-5 levels before (Visit 2-enrollment)	Baseline	No
Secondary	LDL-5 Level After 3 Months of Rosuvastatin Treatment	LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal LDL-6 Level	LDL-6 levels before (Visit 2-enrollment)	Baseline	No
Secondary	LDL-6 Level After 3 Months of Rosuvastatin Treatment	LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal LDL-7 Level	LDL-7 levels before (Visit 2-enrollment)	Baseline	No
Secondary	LDL-7 Level After 3 Months of Rosuvastatin Treatment	LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal Large HDL Subfraction Level	Large HDL subfraction levels before (Visit 2-enrollment)	Baseline	No
Secondary	Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal Intermediate HDL Subfraction Level	Intermediate HDL subfraction levels before (Visit 2-enrollment)	Baseline	No
Secondary	Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Basal Small HDL Subfraction Level	Small HDL subfraction levels before (Visit 2-enrollment)	Baseline	No
Secondary	Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment	Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)	3 months (from enrollment to last visit)	No
Secondary	Number of Patients With Adverse Events	Number of patients with any adverse events in 3 months of rosuvastatin treatment	3 months (from enrollment to last visit)	Yes