ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
Phase 4
Withdrawn
- Conditions
- Primary Hypercholesterolaemia
- Registration Number
- NCT00396240
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 1294
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.