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

Condition(s) targeted: Primary Hypercholesterolaemia

Intervention: Rosuvastatin (Drug); Initiatives to improve compliance (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Madeleine Billeter, MD, Study Director, Affiliation: AstraZeneca
W. Riesen, MD, Principal Investigator, Affiliation: Kantonsspital St. Gallen
R. Darioli, MD, Principal Investigator, Affiliation: CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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:

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: February 2002
Last updated: November 3, 2006