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Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
This study has been completed.
First Received: June 9, 2006   Last Updated: December 12, 2007   History of Changes
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00335699
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: Rosuvastatin
Phase IV

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Rosuvastatin calcium Rosuvastatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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
  • Safety

Estimated Enrollment: 370
Study Start Date: August 2005
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335699

Locations
Korea, Republic of
Research Site
Pusan, Korea, Republic of
Research Site
DaeGu, Korea, Republic of
Research Site
JinJu, Korea, Republic of
Research Site
IkSan, Korea, Republic of
Research Site
KwangJu, Korea, Republic of
Research Site
JeonJu, Korea, Republic of
Research Site
Ulsan, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Korea Medical Director, MD AstraZeneca
  More Information

No publications provided

Study ID Numbers: D3560L00053, KREST
Study First Received: June 9, 2006
Last Updated: December 12, 2007
ClinicalTrials.gov Identifier: NCT00335699     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AstraZeneca:
Hypercholesterolemia with nondiabetic metabolic syndrome

Study placed in the following topic categories:
Antimetabolites
Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Antilipemic Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Pathologic Processes
Rosuvastatin
Therapeutic Uses
Syndrome
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009