Primary Hypercholesterolaemia
Conditions
Keywords
rosuvastatin, hypercholesterolaemia, cholesterol, LDL-C, triglyceride, plasma lipids, compliance
Brief summary
24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.
Interventions
DRUGRosuvastatin
PROCEDUREInitiatives to improve compliance
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
* Primary hypercholesterolaemia: * Statin naïve subjects (LDL-C level \> 3.5 mmol/L) or subjects on an ineffective start dose of a lipid-lowering therapy (LDL-C level \> 3.1 mmol/L). * CV risk \> 20%, * history of CHD or other established atherosclerotic disease
Exclusion criteria
* History of severe adverse events with another HMG-CoA reductase inhibitor * Secondary hypercholesterolaemia; * Unstable cardiovascular disease; * Uncontrolled diabetes, active liver disease; * Severe hepatic or renal impairment; * Treatment with cyclosporin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of rosuvastatin, both with and without compliance initiatives on number and percentage of subjects within the EAS or local LDL-C and TC target goals after 12 week therapy, | — |
| Safety of treatment. | — |
Outcome results
None listed