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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Rosuvastatin

• Study Type: Interventional
• Enrollment: 370
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • DaeGu, Korea, Republic of
    • Research Site
  • IkSan, Korea, Republic of
    • Research Site
  • JeonJu, Korea, Republic of
    • Research Site
  • JinJu, Korea, Republic of
    • Research Site
  • KwangJu, Korea, Republic of
    • Research Site
  • Pusan, Korea, Republic of
    • Research Site
  • Ulsan, Korea, Republic of
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: AstraZeneca Korea Medical Director, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: June 9, 2006
• First Submitted That Met QC Criteria: June 9, 2006
• First Posted (Estimate): June 12, 2006

Study Record Updates

• Last Update Posted (Estimate): December 17, 2007
• Last Update Submitted That Met QC Criteria: December 12, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Hypercholesterolemia with nondiabetic metabolic syndrome
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Metabolic Syndrome; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: D3560L00053; KREST