Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

NCT00335699 | Completed Phase 4

• 2 other identifiers: D3560L00053KREST
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 7

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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia with nondiabetic metabolic syndrome

Outcome Measures

Primary Outcomes (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 Outcomes (7)

• 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

Interventions

Rosuvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Daegu, South Korea

Location

Research Site

Iksan, South Korea

Location

Research Site

Jeonju, South Korea

Location

Research Site

Jinju, South Korea

Location

Research Site

Kwangju, South Korea

Location

Research Site

Pusan, South Korea

Location

Research Site

Ulsan, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• AstraZeneca Korea Medical Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2006
• First Posted: June 12, 2006
• Study Start: August 1, 2005
• Study Completion: January 1, 2007
• Last Updated: December 17, 2007

Record last verified: 2007-12

Locations

KR (7)