Hypercholesterolemia
Conditions
Brief summary
This clinical trial is being performed to investigate the effect of 12 weeks treatment with rosuvastatin and atorvastatin in bringing subjects to their established EAS LDL-C target goal.
Interventions
DRUGRosuvastatin
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Visit 1: 1. Written informed consent to participate in the trial (Appendix B) 2. Male or female subjects, age \> 18 years 3. Primary hypercholesterolaemia with CV risk \> 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L). 4. Subjects may be lipid-lowering therapy-naïve, but have completed 6-weeks dietary counselling before this visit OR Subjects may be treated with the 'start' dose of other lipid lowering therapy, which is ineffective, ie. The subject has not met LDL-C treatment goals. 5. Subjects willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen Visit 2: 6. Subjects switched from start dose of a lipid lowering therapy (commonly accepted start dose) will have fasting LDL-C levels \> 3.1 mmol (120 mg/dl) 7. Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels \> 3.5 mmol/L (135 mg/dL) 8. Fasting triglycerides £ 4.52 mmol/L (400 mg/dL) 9. Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)
Exclusion criteria
1. Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia) 2. Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3 3. History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy 4. Unstable angina within three months prior to inclusion in the study 5. Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT ³ 1.5 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study 6. Known uncontrolled diabetes 7. Uncontrolled hypertension defined as either resting diastolic blood pressure of \> 95mmHg or resting systolic blood pressure of \> 200 mmHg 8. Unexplained serum CK \> 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc) 9. Serum creatinine \> 220 µmol/L (2.5mg/dL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the study are: | — |
| 1. To compare the efficacy of rosuvastatin 10 mg with atorvastatin 10mg by assessment of the percentage of subjects who reach EAS TC treatment goals after 12 weeks of therapy. | — |
| 2. Percentage change in LDL-C, TC, HDL-C and TG from pre-dose (week 0) and 12 weeks which will be performed separately for the switched and the naïve patients. | — |
| 3. To compare rosuvastatin 10 mg with atorvastatin 10 mg after 12 weeks of treatment with respect to the incidence and severity of adverse events and abnormal laboratory values. | — |
Countries
China, Hong Kong, Malaysia, South Korea, Taiwan, Thailand
Outcome results
None listed