Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)
Phase 4
18 Years
69 Years
18 Years
69 Years
Not Enrolling
Both
Metabolic Syndrome
Both
Metabolic Syndrome
Trial Information
Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Basal HDL-cholesterol Level
Outcome Description:
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Outcome Time Frame:
Baseline
Safety Issue:
No
Principal Investigator
Dilek Ural, MD, Prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kocaeli University Faculty of Medicine Cardiology Dept
Authority:
Turkey: Ministry of Health
Study ID:
D3560L00079
NCT ID:
NCT00815659
Start Date:
December 2008
Completion Date:
March 2010
Related Keywords:
- Metabolic Syndrome
- plasma lipid profile
- metabolic syndrome
- Metabolic Syndrome X
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