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Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00335699
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : December 17, 2007
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2005
Actual Study Completion Date : January 2007





Primary Outcome Measures :
  1. 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 :
  1. 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:
  2. Bringing subjects to their established NCEP ATP III target goals for LDL-C
  3. Bringing subjects to their non-HDL target goal(based on NCEP-ATP III criteria)
  4. Modifying other lipids and lipid ratios
  5. Modifying inflammatory markers
  6. Glucose and insulin resistance
  7. Safety


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335699


Locations
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Korea, Republic of
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Korea Medical Director, MD AstraZeneca

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ClinicalTrials.gov Identifier: NCT00335699     History of Changes
Other Study ID Numbers: D3560L00053
KREST
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: December 17, 2007
Last Verified: December 2007

Keywords provided by AstraZeneca:
Hypercholesterolemia with nondiabetic metabolic syndrome

Additional relevant MeSH terms:
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Metabolic Syndrome
Hypercholesterolemia
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors