Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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 treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Rosuvastatin Calcium

Criteria

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.