Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00335699

D3560L00053

KREST

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.