Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00335699
First received: June 9, 2006
Last updated: December 12, 2007
Last verified: December 2007
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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 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
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 | |
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
No publications provided
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00335699 History of Changes |
Other Study ID Numbers: | D3560L00053, KREST |
Study First Received: | June 9, 2006 |
Last Updated: | December 12, 2007 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by AstraZeneca:
Hypercholesterolemia with nondiabetic metabolic syndrome |
Additional relevant MeSH terms:
Hypercholesterolemia Metabolic Syndrome X Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Rosuvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012