Hypercholesterolaemia MedDRA version: 8.1 Level: LLT Classification code 10020603 Term: Hypercholesterolaemia
Conditions
Interventions
Trade Name: Crestor
Product Name: rosuvastatin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Lipitor
Product Name
Sponsors
AstraZeneca UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study dietary run-in period subjects must fulfil all of the following criteria: Visit 1: 1. Provision of written informed consent 2. Self-described Asian, first or second generation (includes origin of India, Pakistan, Bangladesh, Sri Lanka, Nepal, Bhutan, Japan, China, Phillipines, Vietnam , Korea, Indonesia and Malaysia, and the intention to reside in the UK for the duration of the study) 3. Males or females aged = 18 years. There is no upper age limit 4. Subjects with primary hypercholesterolaemia 5. Fasting LDL-C of 3.5 - 5.7 mmol/L (statin naive subjects) or 2.6 - 4.2 mmol/L (in subjects who have taken a statin within 4 weeks of Visit 1)and TG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Use of cholesterol-lowering drugs, the continued use of lipid-regulating dietary supplements or food additives after Visit 1 2. History of serious hypersensitivity reactions to other HMG-CoA reductase inhibitors 3. Pregnancy or lactation. Women of child bearing potential must have a negative pregnancy test at Visit 1, and use a reliable method of contraception i.e. hormonal contraceptives, double-barrier methods, intra-uterine device or tubal ligation, unless their sexual partner is sterile 4. Active arterial disease such as unstable angina, myocardial infarction (MI), transient ischaemic attack (TIA), cerebrovascular accident (CVA), coronary artery bypass graft (CABG) surgery or angioplasty within 3-months of study entry 5. Poorly controlled diabetes, as defined by glycosylated haemoglobin (HbA1c) =9% at Visit 1. Subjects with a history of diabetic ketoacidosis within the past 5-years are also excluded 6. Uncontrolled hypothyroidism as defined as a thyroid stimulating hormone (TSH) > 1.5 X ULN at Visit 1 or subjects whose thyroid replacement therapy was initiated within the last 3 months 7. History of alcohol and/or drug abuse during the preceding 5-years 8. Active liver disease or hepatic dysfunction, as defined by elevations of >3 x ULN at Visit 1 in any of the following liver function tests: alanine aminotranferase (ALT), aspartate aminotranferase (AST) or bilirubin 9. Unexplained serum creatine kinase (CK) >5 x ULN at Visit 1(eg., not due to recent trauma, intra-muscular injections, heavy exercise etc) 10. Renal insufficiency as defined by serum creatinine >177µmol/L (2.0 mg/dL) at Visit 1 11. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the study 12. History of malignancy, except subjects who have been disease-free for more than 5 years, or whose malignancy has been basal or squamous cell skin carcinoma 13. History of homozygous familial hypercholesterolaemia 14. Previous enrolment or randomisation of treatment in this study 15. Participation in another clinical study during the last 90 days. 16. Use of contraindicated concomitant medications, as detailed in section 3.7 17. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) Laboratory results should be reviewed in a timely manner from receipt at site, in order to assess patient’s eligibility for continuation into the dietary lead in/ wash-out period. Following review of results, if a subject no longer meets inclusion/ exclusion criteria the Investigator should contact the subject and inform them that they will no longer be required to participate in the study. In addition, the following are regarded as criteria for exclusion into the randomised treatment period (Visit 3), determined from blood samples taken at visit 2: 18. Active liver disease or hepatic dysfunction, as defined by elevations of >3 x ULN in any of the following liver function tests: alanine aminotranferase (ALT), aspartate aminotranferase (AST) or bilirubin at Visit 2 19. Unexplained serum creatine kinase (CK) >5 x ULN (eg., not due to recent trauma, intra-muscular injections, heavy exercise etc) at Visit 2 20. Serum creatinine >177µmol/L (2.0 mg/dL) at Visit 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this UK study is to compare the efficacy of rosuvastatin 5 mg with atorvastatin 10 mg in reducing LDL-C in Asian subjects with hypercholesterolaemia after 6 weeks of treatment.;Secondary Objective: The secondary objectives of the study are to compare the efficacy of rosuvastatin 5mg with atorvastatin 10mg in Asian subjects with hypercholesterolaemia by assessing: 1. The percentage of subjects reaching the General Medical Services (GMS) contract target of TC <5 mmol/L, after 6 weeks of treatment 2. The percentage of subjects reaching the Joint British Societies’ Guideline (JBS 2) targets of TC <4 mmol/L and LDL-C <2 mmol/L, after 6 weeks of treatment 3. The percentage of subjects reaching the European (EAS) targets for LDL-C or combined LDL-C and TC, dependent on risk category 4. The percentage change from baseline in TC, HDL-C, TG, non-HDL-C, ApoB, ApoA1, LDL-C/HDL-C ratio, TC/HDL-C ratio, non-HDL-C/HDL-C ratio and ApoB/ApoA1 ratio after 6 weeks of treatment 5. The safety and tolerability of treatment with rosuvastatin and atorvastatin during the 6-week treatment period ;Primary end point(s): Reduction in LDL-C from baseline (week 6) to week 12. | — |
Countries
United Kingdom
Outcome results
None listed