Korean Rosuvastatin Effectiveness Study in nondiabetic metabolic syndrome

Study identifier:D3560L00053

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Hypercholesterolemia

Phase

Phase 4

Healthy volunteers

Study drug

Rosuvastatin

Sex

All

Actual Enrollment

370

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Aug 2005

Primary Completion Date: -

Study Completion Date: 01 Jan 2007

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1352&filename=CSR-D3560L00053.pdf
Download
CSR-D3560L00053.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Medical Director

+82-2-2188-0895

Contact Backup

AstraZeneca Korea CV Clinical Research Manager

+82 2 2188 0947

Investigators

Principal Investigator

AstraZeneca Korea Medical Director

AstraZeneca