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Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia with nondiabetic metabolic syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
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  • Research Site

Outcomes

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

Full Information

First Posted
June 9, 2006
Last Updated
December 12, 2007
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00335699
Brief Title
Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Hypercholesterolemia with nondiabetic metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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:
Title
Bringing subjects to their established NCEP ATP III target goals for LDL-C
Title
Bringing subjects to their non-HDL target goal(based on NCEP-ATP III criteria)
Title
Modifying other lipids and lipid ratios
Title
Modifying inflammatory markers
Title
Glucose and insulin resistance
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Korea Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
DaeGu
Country
Korea, Republic of
Facility Name
Research Site
City
IkSan
Country
Korea, Republic of
Facility Name
Research Site
City
JeonJu
Country
Korea, Republic of
Facility Name
Research Site
City
JinJu
Country
Korea, Republic of
Facility Name
Research Site
City
KwangJu
Country
Korea, Republic of
Facility Name
Research Site
City
Pusan
Country
Korea, Republic of
Facility Name
Research Site
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

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Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

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