Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

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

Study Description

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Study Director: AstraZeneca Korea Medical Director, MD; AstraZeneca

More Information

• ClinicalTrials.gov Identifier: NCT00335699
• Other Study ID Numbers: D3560L00053; KREST
• First Posted: June 12, 2006
• Last Update Posted: December 17, 2007
• Last Verified: December 2007

Keywords provided by AstraZeneca:

Hypercholesterolemia with nondiabetic metabolic syndrome

Additional relevant MeSH terms:

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