Status:
WITHDRAWN
ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
Lead Sponsor:
AstraZeneca
Conditions:
Primary Hypercholesterolaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
1294 Patients enrolled
Trial Details
Trial ID
NCT00396240
Start Date
February 1 2002
Last Update
March 26 2009
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