Status:
COMPLETED
Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
Lead Sponsor:
AstraZeneca
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00335699
Start Date
August 1 2005
End Date
January 1 2007
Last Update
December 17 2007
Active Locations (7)
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1
Research Site
Daegu, South Korea
2
Research Site
Iksan, South Korea
3
Research Site
Jeonju, South Korea
4
Research Site
Jinju, South Korea