ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Rosuvastatin Calcium

Criteria

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.