Rosuvastatin ORBITAL Germany

Condition(s) targeted: Hypercholesterolemia

Intervention: Rosuvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Wolfgang Meyer - Sabellek, MD, Study Director, Affiliation: AstraZeneca Germany
Stefan Stefan Willich, MD, Principal Investigator, Affiliation: Charité Berlin, Germany

The primary objective of the study is to compare the effect of rosuvastatin therapy plus compliance initiatives and rosuvastatin therapy alone for 12 months (52 weeks) on long-term cumulative direct and indirect disease-related costs during the 36 month.

Official title: Effects of a Twelve Months ROSUVASTATIN Treatment Plus Additional Care (Drug Intake Adherence and Lifestyle Enhancing Initiatives ) Compared to ROSUVASTATIN Treatment Alone on Long-Term Disease-Related Costs in Patients With an Indication for Statin Treatment According to the Joint European Guidelines

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

Primary outcome:

Cumulative direct/indirect disease-related costs were compared applying a societal perspective

Costs include resource utilization for ambulatory, hospital, rehabilitative and nursing care, medication, physiotherapy, transportation, and productivity loss)

Secondary outcome:

Achievement of the 1998 European LDL-C goal of <115 mg/dL (3.0 mmol/L)

Changes in the lipid profile and compliance with therapy.

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

Criteria:

Inclusion Criteria:

- high cholesterol with an indication for cholesterol-lowering medication (statins)

Exclusion Criteria:

- contra-indications for statin therapy

Starting date: February 2002
Last updated: September 20, 2006