Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Korea Medical Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Pusan, Korea, Republic of
Research Site, DaeGu, Korea, Republic of
Research Site, JinJu, Korea, Republic of
Research Site, Ulsan, Korea, Republic of
Research Site, KwangJu, Korea, Republic of
Research Site, JeonJu, Korea, Republic of
Research Site, IkSan, Korea, Republic of
Additional Information
Starting date: August 2005
Ending date: January 2007
Last updated: December 12, 2007
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