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

AstraZeneca1,294 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,294

Conditions

Primary Hypercholesterolaemia

Interventions

RosuvastatinDRUG

Initiatives to improve compliancePROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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