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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Research Site
  • Trabzon, Turkey
    • Research Site
  • Besevler
    • Ankara, Besevler, Turkey
      • Research Site
  • Erciyes
    • Kayseri, Erciyes, Turkey
      • Research Site
  • Haseki
    • Istanbul, Haseki, Turkey
      • Research Site
  • Umuttepe
    • Kocaeli, Umuttepe, Turkey
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin; medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.	Drug: rosuvastatin; medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.; Other Names: CRESTOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basal HDL-cholesterol Level	HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)	Baseline
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)
Basal LDL-cholesterol Level	LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)	Baseline
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)
Basal Total Cholesterol Level	Baseline	Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
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)
Basal Triglyceride Level	Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)	Baseline
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)
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)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basal Interleukin 1 (IL-1) Level	IL-1 levels before (Visit 2-enrollment)	Baseline
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)
Basal Interleukin 6 (IL-6) Level	IL-6 levels before (Visit 2-enrollment)	Baseline
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)
Basal Interleukin 8 (IL-8) Level	IL-8 levels before (Visit 2-enrollment)	Baseline
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)
Basal Interleukin 10 (IL-10) Level	IL-10 levels before (Visit 2-enrollment)	Baseline
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)
Basal Tumor Necrosis Factor (TNF) Level	TNF levels before (Visit 2-enrollment)	Baseline
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)
Basal High Sensitivity C-reactive Protein (Hs-CRP) Level	hs-CRP levels before (Visit 2-enrollment)	Baseline
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)
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
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)
Basal LDL-4 Level	LDL-4 levels before (Visit 2-enrollment)	Baseline
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)
Basal LDL-5 Level	LDL-5 levels before (Visit 2-enrollment)	Baseline
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)
Basal LDL-6 Level	LDL-6 levels before (Visit 2-enrollment)	Baseline
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)
Basal LDL-7 Level	LDL-7 levels before (Visit 2-enrollment)	Baseline
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)
Basal Large HDL Subfraction Level	Large HDL subfraction levels before (Visit 2-enrollment)	Baseline
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)
Basal Intermediate HDL Subfraction Level	Intermediate HDL subfraction levels before (Visit 2-enrollment)	Baseline
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)
Basal Small HDL Subfraction Level	Small HDL subfraction levels before (Visit 2-enrollment)	Baseline
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)
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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Dilek Ural, MD, Prof, Kocaeli University Faculty of Medicine Cardiology Dept

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: December 29, 2008
• First Submitted That Met QC Criteria: December 29, 2008
• First Posted (Estimate): December 30, 2008

Study Record Updates

• Last Update Posted (Estimate): August 31, 2011
• Last Update Submitted That Met QC Criteria: August 29, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: metabolic syndrome; plasma lipid profile
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: D3560L00079