Clinical trial NCT00815659: Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Keywords: plasma lipid profile
metabolic syndrome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-30
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Basal HDL-cholesterol Level
timeFrame: Baseline
measure: HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal LDL-cholesterol Level
timeFrame: Baseline
measure: LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Total Cholesterol Level
timeFrame: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
measure: Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Triglyceride Level
timeFrame: Baseline
measure: Triglyceride Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
Secondary outcomes:
measure: Basal Interleukin 1 (IL-1) Level
timeFrame: Baseline
measure: Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Interleukin 6 (IL-6) Level
timeFrame: Baseline
measure: Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Interleukin 8 (IL-8) Level
timeFrame: Baseline
measure: Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Interleukin 10 (IL-10) Level
timeFrame: Baseline
measure: Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Tumor Necrosis Factor (TNF) Level
timeFrame: Baseline
measure: Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal High Sensitivity C-reactive Protein (Hs-CRP) Level
timeFrame: Baseline
measure: High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal LDL-3 Level
timeFrame: Baseline
measure: LDL-3 Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal LDL-4 Level
timeFrame: Baseline
measure: LDL-4 Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal LDL-5 Level
timeFrame: Baseline
measure: LDL-5 Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal LDL-6 Level
timeFrame: Baseline
measure: LDL-6 Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal LDL-7 Level
timeFrame: Baseline
measure: LDL-7 Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Large HDL Subfraction Level
timeFrame: Baseline
measure: Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Intermediate HDL Subfraction Level
timeFrame: Baseline
measure: Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Basal Small HDL Subfraction Level
timeFrame: Baseline
measure: Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment
timeFrame: 3 months (from enrollment to last visit)
measure: Number of Patients With Adverse Events
timeFrame: 3 months (from enrollment to last visit)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Research site
state: Besevler
city: Kayseri
country: Turkey
facility: Research site
state: Erciyes
city: Istanbul
country: Turkey
facility: Research site
state: Haseki
city: Kocaeli
country: Turkey
facility: Research site
state: Umuttepe
city: Izmir
country: Turkey
facility: Research Site
city: Trabzon
country: Turkey
facility: Research Site
Study officials:
affiliation: Kocaeli University Faculty of Medicine Cardiology Dept
name: Dilek Ural, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: