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

AstraZeneca

Status and phase: Withdrawn; Phase 4

Conditions: Primary Hypercholesterolaemia

Treatments: Drug: Rosuvastatin; Procedure: Initiatives to improve compliance

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396240

ORBITAL

D3560L00008

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)