Korean Rosuvastatin Effectiveness Study in Nondiabetic Metabolic Syndrome

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335699
• Other study ID #: D3560L00053
• Secondary ID: KREST
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2006
• Last updated: December 12, 2007
• Start date: August 2005
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Metabolic Syndrome X

Intervention

Drug:
• Rosuvastatin

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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:
Secondary	Bringing subjects to their established NCEP ATP III target goals for LDL-C
Secondary	Bringing subjects to their non-HDL target goal(based on NCEP-ATP III criteria)
Secondary	Modifying other lipids and lipid ratios
Secondary	Modifying inflammatory markers
Secondary	Glucose and insulin resistance
Secondary	Safety