Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

NCT ID: NCT00335699

Last Updated: 2007-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 370 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-01-31

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 treatment.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia with nondiabetic metabolic syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rosuvastatin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Korea Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Daegu, , South Korea

Research Site

Iksan, , South Korea

Research Site

Jeonju, , South Korea

Research Site

Jinju, , South Korea

Research Site

Kwangju, , South Korea

Research Site

Pusan, , South Korea

Research Site

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

KREST

Identifier Type: -

Identifier Source: secondary_id

D3560L00053

Identifier Type: -

Identifier Source: org_study_id