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Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
This study has been completed.
Study NCT00335699   Information provided by AstraZeneca
First Received: June 9, 2006   Last Updated: December 12, 2007   History of Changes
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June 9, 2006
December 12, 2007
August 2005
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome after 6 weeks of treatment.
Same as current
Complete list of historical versions of study NCT00335699 on ClinicalTrials.gov Archive Site
  • The secondary objectives of this study are to compare the effects of rosuvastatin 10mg with atorvastatin 10mg in subjects with metabolic syndrome, after 6weeks of treatment, on:
  • Bringing subjects to their established NCEP ATP III target goals for LDL-C
  • Bringing subjects to their non-HDL target goal(based on NCEP-ATP III criteria)
  • Modifying other lipids and lipid ratios
  • Modifying inflammatory markers
  • Glucose and insulin resistance
  • Safety
  • The secondary objectives of this study are to compare the effects of rosuvastatin 10mg with atorvastatin 10mg in subjects with metabolic syndrome, after 6weeks of treatment, on:
  • Bringing subjects to their established NCEP ATP III target goals for LDL-C
  • Bringing subjects to their non-HDL target goal(based on NCEP-ATP III criteria)
  • Modifying other lipids and lipid ratios
  • Modifying inflammatory markers
  • Glucose and insulin resistance
  • Safety
 
Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
A 6-Week, Randomised, Open-Label, Parallel Group, Multi-Centre Study to Compare the Efficacy of Rosuvastatin 10mg With Atorvastatin 10mg in the Treatment of Non-Diabetic Metabolic Syndrome Subjects With Raised LDL-C

The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg in the percentage reduction of LDL-C in Subjects with metabolic syndrome after 6 weeks of treatment.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Hypercholesterolemia
Drug: Rosuvastatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
370
January 2007
 

Inclusion Criteria:

  • Metabolic syndrome patient; Presence of 3 or more of the following:

    • Abdominal obesity (waist circumference): men > 90cm(36 inch), women > 80cm(32 inch)
    • Triglycerides ≥ 150 mg/dL (1.70 mmol/L)
    • HDL-C: men < 40 mg/dL (1.04 mmol/L), women < 50 mg/dL (1.3 mmol/L)
    • BP ≥130/≥85 mmHg or subject receiving anti-hypertensive treatment
    • Fasting blood glucose 110 mg dL (6.11 mmol/L) - 125 mg/dL (6.94 mmol.L)
  • Elevated LDL-C concentrations reported within 4 weeks of visit 1 as follows;

    • ≥ 130 mg/dL (3.36 mmol/L) to < 220 mg/dL (5.69 mmol/L) in statin naive subjects (subjects who have not taken any lipid-lowering therapy known to affect LDL-C in the 4 weeks prior to visit 1)
    • ≥ 100 mg/dL (2.59 mmol/L) to < 160 mg/dL (4.14 mmol/L) in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1
  • Triglyceride levels < 400 mg/dL (4.52 mmol/L)
  • Women of childbearing potential should be using a medically acceptable form of chemical or mechanical contraception.

Exclusion Criteria:

  • History of known diabetes mellitus
  • Use of anti-hyperglycaemic medication.
  • History of serious or hypersensitivity reactions to HMG-CoA reductase inhibitors, in particular history of myopathy.
  • No CHD or CHD Risk Equivalents and 0-1 Risk factors and Framingham 10-Year risk is <10%.
  • History of heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
  • Active arterial disease such as unstable angina pectoris, myocardial infarction, transient ischaemic attack (TIA), cerebrovascular accident (CVA), coronary artery bypass surgery (CABG) or angioplasty within 2 months prior to entry in the dietary lead in period
  • Uncontrolled hypothyroidism defined as thyroid stimulating hormone (TSH) > 1.5 times the upper limit of normal (ULN) at Visit 2 or subjects whose thyroid replacement therapy was initiated within 3 months of entry into dietary lead-in phase.
  • Current active liver disease (alanine aminotransferase [ALT] > 2 x ULN) or severe hepatic impairment.
  • Unexplained serum CK >3 times ULN (e.g. not due to recent trauma, intramuscular injections, heavy exercise, etc).
  • Serum creatinine > 176 umol/L (2.0 mg/dL)
  • History of alcohol, or drug, abuse or both.
Both
18 Years and older
No
 
Korea, Republic of
 
 
NCT00335699
 
KREST
AstraZeneca
 
Study Director: AstraZeneca Korea Medical Director, MD AstraZeneca
AstraZeneca
December 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.